[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm-birth\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm-birth":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,50,85,132,159,205,228,262,290,313,341,363,389,419,442,483,516,554,585,605,636,661,685,713,753],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100054173","maternal-periodontal-inflammation-and-pregnancy-outcomes-salivary-and-amniotic-biomarkers-100054173",false,"NCT07699978","Maternal Periodontal Inflammation and Pregnancy Outcomes: Salivary and Amniotic Biomarkers","The Relationship Between Maternal Periodontal Inflammation and Pregnancy Outcomes: Evaluation Using Inflammatory and Oxidative Stress Biomarkers in Saliva and Amniotic Fluid","Inclusion Criteria:\n\nPregnant women between 28 and 32 weeks of gestation Age 18 to 40 years Singleton pregnancy Systemically healthy Normal gestational diabetes screening (oral glucose tolerance test within the hospital reference range) Receiving only routine prenatal vitamin and iron supplementation (no therapeutic medications) Low-risk pregnancy No history of chorioamnionitis No periodontal treatment within the previous 6 months Able and willing to provide written informed consent\n\nExclusion Criteria:\n\nMultiple pregnancy Use of antibiotics or anti-inflammatory medications during pregnancy Current smoking or alcohol consumption Presence of an acute infection Placental pathology Major fetal anomaly High-risk pregnancy as determined by the obstetrician Refusal or inability to provide informed consent",true,"FEMALE","18 Years","40 Years",{"count":22,"type":23},80,"ESTIMATED","OBSERVATIONAL","Periodontal disease is a chronic inflammatory condition that affects the tissues supporting the teeth and may contribute to systemic inflammation and oxidative stress. Increasing evidence suggests that maternal inflammation during pregnancy may be associated with adverse pregnancy outcomes, including preterm birth. However, the biological mechanisms linking maternal periodontal inflammation to the intrauterine environment remain unclear.\n\nThis prospective observational cohort study aims to investigate the relationship between maternal periodontal status and inflammatory and oxidative stress biomarkers measured in both saliva and amniotic fluid. Eighty healthy pregnant women between 28 and 32 weeks of gestation will be recruited from the Obstetrics and Gynecology Clinic of Gulhane Training and Research Hospital. Participants will undergo a comprehensive periodontal examination and provide unstimulated saliva samples. Amniotic fluid samples will be collected during delivery as part of routine obstetric care, without any additional invasive procedures.\n\nThe concentrations of 8-hydroxy-2'-deoxyguanosine (8-OHdG), malondialdehyde (MDA), interleukin-6 (IL-6), and matrix metalloproteinase-8 (MMP-8) will be measured in saliva and amniotic fluid using enzyme-linked immunosorbent assay (ELISA). Pregnancy outcomes, including gestational age at delivery, birth weight, and pregnancy complications, will also be recorded.\n\nThe study will evaluate whether maternal periodontal inflammation is associated with changes in inflammatory and oxidative stress biomarkers in saliva and amniotic fluid and whether these biomarkers are related to pregnancy outcomes. The findings may improve understanding of the biological relationship between oral health and pregnancy and may contribute to the identification of biomarkers associated with adverse pregnancy outcomes.",[27,28,29],"Periodontal Disease","Pregnancy","Preterm Birth",[31,28,29,32,33,34,35,36,37],"Periodontitis","Oxidative Stress","Inflammation","Saliva","Amniotic Fluid","8-Hydroxy-2'-deoxyguanosine (8-OHdG)","Interleukin-6 (IL-6)","NOT_YET_RECRUITING","2026-07-07",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":23},"2026-08-20",{"date":46,"type":23},"2027-08-15",{"name":48,"class":49},"Saglik Bilimleri Universitesi","OTHER",{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":57,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100053703","de-restrict-deimplementing-activity-restriction-for-preterm-birth-prevention-100053703","NCT07698483","DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention","Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial","Inclusion Criteria:\n\n* For Providers: Physicians, midwives, physician assistants, nurse practitioners, nurses, nursing assistants, medical assistants, and other healthcare staff who provide or participate in prenatal or high-risk pregnancy care or consultation at a participating site.\n* For Patients: Secondary patient-reported outcomes draw on pregnant individuals at high risk for preterm birth (qualifying diagnoses include short cervix, cervical insufficiency, multiple gestation, preterm labor, preterm contractions, vaginal bleeding, placental conditions, or a history of prior preterm birth), between 0 and 12 weeks postpartum for the survey measures. The activity restriction recommendation measure is collected through the Take Home Electronic Assessment (THEA) and therefore reaches only patients enrolled in THEA, at 33 weeks of gestation, across all periods; in the pre-deimplementation and post-deimplementation periods the additional survey battery is sent only to patients with a qualifying high-risk diagnosis.\n\nExclusion Criteria:\n\n* For Providers: Staff who self-exclude by choosing not to interact with deimplementation meetings and communications\n* For Patients: Patients are excluded if they are unable to walk or are hospitalized without discharge home before delivery after the qualifying diagnosis is made.","ALL",{"count":59,"type":23},237,"INTERVENTIONAL",[62],"NA","DE-RESTRICT is a pilot study testing whether a strategy to reduce the use of activity restriction and bedrest in pregnancy is acceptable, appropriate, and feasible for prenatal care providers, and whether it changes how often activity restriction is recommended. Activity restriction and bedrest are commonly advised to try to prevent preterm birth, but they do not prevent it and may cause harm, and national guidelines recommend against them. The study takes place at two prenatal care settings within one health system and unfolds across four periods. In the pre-deimplementation period the study team develops a local clinical guideline and measures baseline outcomes. In the run-in period most provider education is delivered through interactive sessions with feedback, and audit and feedback begins. In the maintenance period audit and feedback continues. In the post-deimplementation period audit and feedback continues and outcomes are measured again. The study measures provider acceptability, appropriateness, and feasibility, the rate of activity restriction recommendations, patient-reported wellbeing and care experience, and the preterm birth rate.",[29,65,66,67],"Activity Restriction","Bed Rest","Low-Value Care",[69,70,71,72,73,74,75,76],"deimplementation","low-value care","activity restriction","bedrest","preterm birth","audit and feedback","implementation science","hybrid trial",{"date":41,"type":42},{"date":79,"type":23},"2026-07-01",{"date":81,"type":23},"2027-08-31",{"name":83,"class":49},"University of Pennsylvania",2,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":17,"sex":18,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":60,"phases":96,"briefSummary":97,"conditions":98,"keywords":106,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100628220","healthy-expectancy-through-routine-antenatal-sti-screening-100628220","NCT07458802","Healthy Expectancy Through Routine Antenatal STI Screening","Screening and Treatment for Chlamydia Trachomatis Infection to Prevent Preterm Birth","HERA","Inclusion Criteria:\n\n1. Asymptomatic for cervicovaginitis at first ANC (i.e., not syndromically treated for an STI by clinic midwives at first ANC)\n2. Age ≥ 15 years\n3. Currently pregnant\n4. ≤20 weeks gestation (based on gestational age in obstetric record or last menstrual period if gestational age missing from record)\n5. Attending first ANC visit\n6. Residence in Gaborone, Bostwana or surrounding villages through the time of delivery\n7. Mentally competent to understand study procedures or give informed consent","15 Years",{"count":95,"type":23},2000,[62],"This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system.\n\nAbout 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups:\n\n1. Standard of care group: Women receive routine antenatal care only.\n2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester.\n\nThe main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.",[99,100,101,102,103,104,105,29],"Antenatal Health","Antenatal Care","STI","Chlamydia Trachomatis Infection in Pregnancy","Chlamydia","Chlamydia Trachomatis","Chlamydia Trachomatis Infection",[107,108,109,110,111,112,113,101,114,115,116,117,118,119,120],"antenatal health","antenatal screening","chlamydia","chlamydia trachomatis","chlamydia screening","chlamydia treatment","pregnancy screening","STI screening","STI in pregnancy","preterm delivery","Botswana","CT infection","chlamydia in pregnancy","birth outcomes","RECRUITING","2026-06-30",{"date":124,"type":42},"2026-07-02",{"date":126,"type":42},"2026-05-25",{"date":128,"type":23},"2030-07-01",{"name":130,"class":49},"Adriane Wynn",1,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":17,"sex":57,"minAge":4,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":60,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100623902","does-ai-make-clinicians-more-appropriately-confident-a-randomized-study-in-preterm-birth-prediction-100623902","NCT07402668","Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction","Inclusion Criteria:\n\n* Medical doctors currently working in or training within the field of obstetrics and gynecology.\n* Experience performing transvaginal cervical ultrasound examinations.\n\nExclusion Criteria:\n\n\\- No prior experience performing transvaginal cervical ultrasound examinations.",{"count":139,"type":23},125,[62],"The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and gynecology when assessing the risk of spontaneous preterm birth using clinical case vignettes with cervical ultrasound images. The study specifically compares two AI presentation formats: a binary classification (preterm vs term birth) and an individualized risk estimate of preterm birth.\n\nThe main questions it aims to answer are:\n\n* Which AI presentation format leads to better alignment between clinicians' confidence and decision accuracy (diagnostic calibration)?\n* Do different AI presentation formats lead to helpful or harmful changes in clinical decisions?\n\nParticipants will complete an online questionnaire in which they review clinical cases, make diagnostic and management decisions, rate their diagnostic confidence before and after seeing the AI output, and report their trust in the AI.",[29,143],"Artificial Intelligence (AI) in Diagnosis",[145,146,147,148,149,150],"Preterm birth","Premature birth","Diagnostic calibration","Diagnostic accuracy","Diagnostic confidence","Artificial intelligence",{"date":79,"type":42},{"date":153,"type":42},"2026-02-03",{"date":155,"type":23},"2026-07",{"name":157,"class":49},"Rigshospitalet, Denmark",18,{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":60,"phases":169,"briefSummary":170,"conditions":171,"keywords":192,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":131},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442","NCT06915428","Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities","Personalized Toolkit Building a Comprehensive Approach to Resource Optimization and Empowerment in Pregnancy & Beyond (PTBCARE+) A Randomized Controlled Trial (RCT) of Personalized Care for Prenatal Stress Reduction and Preterm Birth Disparities Prevention","PTBCARE+","Inclusion Criteria:\n\n1. Viable, singleton pregnancy, 8+0 to 19+6 weeks, dated by last menstrual period ± ultrasound using standard obstetric criteria per American College of Obstetricians and Gynecologists.\n\n   Gestational age at first ultrasound by last menstrual period (LMP) \u002F Ultrasound method \u002F Measurement agreement with LMP required • Up to 8 weeks 6 days \u002F crown rump length \u002F ± 5 days\n   * 9 weeks 0 days to 13 weeks 6 days \u002F crown rump length \u002F ± 7 days\n   * 14 weeks 0 days to 15 weeks 6 days \u002F standard fetal biometry \u002F ± 7 days\n   * 16 weeks 0 days to 19 weeks 6 days \u002F standard fetal biometry \u002F ± 10 days\n   * Gestational dating \u002F fetal viability must be confirmed by ultrasound prior to enrollment \u002F randomization.\n   * Ultrasound report must include documentation of normal fetal heart rate of ≥ 120 beats per minute, or subsequent medical record documentation of auscultation of fetal heart rate ≥ 120 beats per minute.\n   * Viability must be confirmed \u002F re-confirmed within 7 days of randomization.\n\n   If initial consent occurs early in pregnancy and V1\u002Frandomization occur later, viability must be reconfirmed to ensure ongoing eligibility prior to initiating V1 activities (including surveys) and proceeding with randomization.\n2. No signs or symptoms of, or clinical diagnosis of, evolving miscarriage, active preterm labor, preterm prelabor rupture of membranes at the time of enrollment.\n\n   * Cervical dilation at the time of enrollment is an exclusion criterion. However, cervical evaluation and digital cervical exam is not required prior to enrollment.\n\n     (3a) High a priori risk for medically indicated preterm birth - must meet at least one of the following 3 criteria (maternal medical history, prior pregnancy history, or moderate risk factor history)\n   * miPTB criteria #1: Maternal Medical History - any one of the following:\n\n     o Known chronic hypertension requiring medications in the 3 months prior to conception or prior to 22 weeks gestation.\n\n     o At least 2 blood pressure readings 6 hours apart, \\\u003C20 weeks gestation, with systolic ≥ 130 mmHg or diastolic ≥ 80 mmHg \\*regardless of need for medication or formal diagnosis of hypertension in chart\\*\n\n     o Pre-gestational diabetes mellitus.\n     * Diabetes diagnosed \\\u003C20 weeks gestation.\n     * Maternal chronic or sub-acute renal disease, including chronic kidney failure, chronic renal insufficiency, glomerulonephritis, lupus nephritis, defined as any:\n\n       \\*biopsy proven chronic renal disease history; and\u002For\n\n       \\*serum creatinine ≥ 1.1 mg\u002FdL at any time during pregnancy prior to enrollment, in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis); and\u002For\n\n       \\*chronic proteinuria, defined as baseline urine protein:creatinine ratio ≥ 0.30 mg\u002FdL or 24 hour total urine protein ≥ 300 mg in the absence of other identifiable transient factors per clinician's assessment (e.g., extreme dehydration, cystitis, pyelonephritis)\n\n       \\*Systemic Lupus Erythematosus\n       * Antiphospholipid Antibody Syndrome\n   * miPTB criteria #2: Prior pregnancy history - any ONE of the following: o Previous pregnancy complicated by preeclampsia or hypertensive disorders of pregnancy at any gestational age, in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Previous history of stillbirth ≥ 16+0 weeks in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy. The stillbirth etiology must not have been attributed to physical trauma (e.g., domestic violence, motor vehicle accident) or illicit drug use (e.g., cocaine use leading to abruption and stillbirth).\n   * miPTB criteria #3: Any two or more of the following moderate risk factors: o Nulliparity, defined as no prior pregnancy to reach at least 20 weeks gestation note that this is the traditional \u002F classic definition of 'nulliparous' and that there is overlap between nulliparity as defined this way and 'preterm birth' due to cervical insufficiency, which allows for deliveries in the 16-19 week gestational age range to be considered as 'preterm births'\n\n     o Obesity: current or pre-pregnancy body mass index ≥30 kg\u002Fm\\^2\n\n     o Family history: first degree relative with a history of preeclampsia\n\n     o Advanced maternal age: maternal age ≥ 35 years at estimated date of confinement\n\n     o Prior adverse obstetric history - one or more of the following:\n\n     \\- history of low birth weight or small for gestational age baby in a singleton gestation, defined as weight \\\u003C10% for gestational age and fetal sex; the fetus must not have had major structural anomalies or aneuploidy.\n\n     \\- history of adverse pregnancy outcome in a singleton gestation; the fetus must not have had major structural anomalies or aneuploidy.\n\n     o Long interpregnancy interval: ≥ 10 year (3650 day) pregnancy interval, defined as the time (in days) between the date of delivery of the last pregnancy to reach ≥ 20 weeks gestation and the first day of the last menstrual period for the current pregnancy.\n\n     o Black or African-American race (as a proxy for underlying racism) - self-reported. Participants who self-identify as being of more than one racial group will be considered to be of Black race for the purposes of this criterion if one of the racial groups is Black or African-American.\n     * Low socioeconomic status, defined as one or more of the following: housing or food insecurity noted in chart within the last year, self-pay or Medicaid insurance, less than high school education\n\nand\u002For\n\n(3b) High a priori risk for spontaneous preterm birth - must meet at least one of the following 2 criteria (prior pregnancy history or current pregnancy course)\n\n* sPTB criteria #1: Prior pregnancy history\n\n  * EITHER a history of a delivery of a singleton, non-anomalous baby between 16+0 and 34+6 weeks gestation or delivery of a twin, non-anomalous pregnancy between 160 \u002F7and 276 \u002F7 weeks gestation due to spontaneous preterm labor, preterm premature rupture of membranes, cervical insufficiency, or placental abruption - Chart documentation of prior preterm birth, the gestational age of the prior preterm birth (referred to as the 'qualifying delivery') should be determined. If the gestational age at delivery is obtained directly from the medical record and more than one gestational age appears, the greater of the two will be used assuming that neither is the 'source document' (i.e. an ultrasound report with a due date, a c-section report, a delivery note, etc).\n\nUse the following table as a validation of the previous delivery. For example, if the infant was male and weighed more than 2763 grams (6 pounds, 1.5 ounces) then the patient would be ineligible based on history of a preterm birth criteria. This table should only be used to determine whether the qualifying delivery is most likely to be preterm less than 35 weeks gestation when the gestational age CANNOT be verified\u002Fcalculated by review of the medical records or is not available in the medical records.\n\nGestational age 90th percentile - boys 90th percentile - girls 33 weeks \\> 2488g 5 lbs 7.8 oz \\> 2116g 4 lbs 10.6 oz 34 weeks \\> 2763g 6 lbs 1.5 oz \\> 2379g 5 lbs 3.9 oz 35 weeks \\> 3084g 6 lbs 12.8 oz \\> 2661g 5 lbs 13.9 oz\n\n* Documented history of a prior pregnancy complicated by asymptomatic cervical shortening \\\u003C25mm between 16+0 and 23+6 weeks gestation or cervical dilation ≥ 0.5cm requiring cervical cerclage placement prior to 24+0 weeks gestation, even if delivery ultimately occurred ≥ 35 weeks gestation or at term.\n\n  • sPTB criteria #2: Current pregnancy course\n* Asymptomatic cervical shortening \\\u003C25mm in the current pregnancy, diagnosed by transvaginal ultrasound that is performed ≥14+0 weeks gestation, per Registered Diagnostic Medical Sonographer(RDMS) certified Sonographer or physician with transvaginal ultrasound training program (or similar) qualifications\n* Cervical cerclage in situ in the current pregnancy due to concern for risk of preterm birth, at the discretion of the primary obstetric provider\n\n  (4) Ability to provide written, informed consent in English or Spanish\n\n  (5) Planned prenatal care at the University of North Carolina at Chapel Hill obstetrics clinics and planned delivery at the University of North Carolina Women's Hospital (Chapel Hill, NC).\n\nExclusion Criteria:\n\n1. Participation in another intervention based clinical trial during pregnancy that is deemed, at the discretion of the investigative team for the current study or the other concurrent study, to conflict with this research and\u002For confound the study results.\n\n   o There are some concurrent studies, even those designed to test an intervention, which may be compatible with the current study; this will be reviewed by the investigative leadership team on a case-by-case basis.\n2. Previous participation in the PTBCARE+ program in another pregnancy, with randomization to the PTBCARE+ (active intervention) group.\n3. Current, ongoing, illicit drug use ≥ 12 weeks gestation.\n\n   * Use of tobacco and\u002For marijuana products is not an exclusion.\n   * Receiving treatment for opioid use disorder with methadone, suboxone, or similar in an approved treatment program is not an exclusion.\n4. History of radical trachelectomy\n5. Planned voluntary termination of pregnancy.\n6. Heavy vaginal bleeding or large subchorionic hemorrhage - defined as:\n\n   * Bleeding as primary reason for unplanned clinic evaluation or emergency room visit within 14 days of potential enrollment\n   * Subjective bleeding accompanied by ≥ 4 point drop in the hematocrit within 14 days of potential enrollment\n   * Subchorionic hemorrhage or abruption on formal ultrasound with a volume ≥ 64 cubic cm (4cm x 4cm x 4cm) within 14 days of potential enrollment\n7. Major congenital anomaly such as major structural deficit of the heart, lungs, brain, or other major organ system\n\n   1. Mild renal abnormalities, clubfoot, isolated cleft lip\u002Fpalate, etc. in the fetus are not a reason for exclusion.\n   2. Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion.\n   3. If a major congenital anomaly is diagnosed \\*after\\* enrollment, the patient will continue to participate in the study, however, the investigators will plan to analyze the study results with and without these individuals included.\n8. Positive aneuploidy screening test (traditional biochemical assay, e.g., quad screen - risk of aneuploidy of 1:25 or higher or cell free deoxynucleic acid (DNA) test result that is screen positive for trisomy 13, trisomy 18, trisomy 21, or sex chromosome abnormality) in the absence of definitive fetal karyotype evaluation.\n\n   * Definitive fetal karyotype evaluation can only be obtained through direct testing of the tissue from the conceptus - by chorionic villus sampling or amniocentesis during pregnancy.\n   * The term \"suspected aneuploidy\" is commonly used in the medical record but this is not a diagnosis and by itself is not informative and not an exclusion criteria.\n9. Cystic hygroma or abnormally thickened nuchal translucency ≥ 3 mm at any time in the current gestation, regardless of subsequent diagnostic testing results.\n\n   * Note that a cystic hygroma remains an exclusion criterion regardless of subsequent diagnostic testing results because fetuses with this history carry an elevated risk of major congenital heart disease.\n   * Fetal echocardiogram is most accurately performed at 22-24 weeks gestation, which is later than the enrollment gestational age window.\n10. Polyhydramnios at or prior to enrollment.\n\n    o Polyhydramnios is defined as a maximum vertical pocket ≥ 8.0 cm, given that polyhydramnios \\\u003C22 weeks has a high likelihood of being associated with congenital anomalies\u002Faneuploidy and\u002For preterm birth due to preterm prelabor rupture of membranes.\n11. For potential participants who meet eligibility criteria ONLY due to prior spontaneous or medically indicated preterm birth: if the prior preterm birth was in a pregnancy complicated by twins, confirmed fetal aneuploidy, or major congenital fetal anomalies in the absence of another pregnancy meeting inclusion criteria they are not eligible.\n12. Known HIV positive with viral load greater than 1,000 copies\u002FmL or cluster of differentiation 4 (CD4) count less than 350\u002Fmm\\^3\n13. Unwillingness to undergo randomization.",{"count":168,"type":23},1228,[62],"The goal of this clinical trial is to learn if a personalized prenatal support program \\[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \\& Beyond, (PTBCARE+)\\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\\[s\\] it aims to answer are:\n\n* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?\n* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?\n* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?\n\nResearchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.\n\nParticipants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.\n\nAll participants will be asked to:\n\n* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.\n* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.\n\nPeople who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:\n\n* a stress reduction toolkit;\n* access to an online website that can also be downloaded as a smart phone app;\n* the option to receive an electronic massage while in clinic, and more.\n* additional support gifts provided at routine clinical appointments\n\nPeople who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.",[172,29,173,174,175,176,177,178,179,180,181,28,182,183,184,185,186,187,188,189,190,191],"Preterm Birth Complication","Preterm Birth Recurrence","Preeclampsia","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy Complications","Pregnancy Induced Hypertension","Neonates and Preterm Infants","Cervical Insufficiency","Social Determinants of Health (SDOH)","Cervical Shortening","Disparities in Pregnancy Complications","Disparities","Prenatal Care","Care Coordination",[165,193,194,195],"pregnancy-related disparities","patient support program","enhanced prenatal care","2026-06-25",{"date":198,"type":42},"2026-06-29",{"date":200,"type":23},"2026-08-01",{"date":202,"type":23},"2029-01",{"name":204,"class":49},"University of North Carolina, Chapel Hill",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":17,"sex":18,"minAge":212,"maxAge":20,"enrollmentInfo":213,"targetDuration":4,"studyType":60,"phases":215,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":131},"100499765","phase-4-prolonged-progesterone-to-prevent-preterm-birth-from-ivf---et-100499765","NCT05787509","Prolonged Progesterone to Prevent Preterm Birth From IVF - ET","The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial","Inclusion criteria are: age 20-40 years; meeting the indications for assisted reproductive technology (ART) and undergoing fresh embryo transfer with in vitro fertilization (IVF); singleton pregnancy; and willingness to participate and provide written informed consent.\n\nExclusion criteria are: age \\>40 years; history of second-trimester miscarriage or cervical insufficiency; ovarian dysfunction or relevant surgical history; uterine malformation; diseases associated with abnormal uterine cavity morphology; abnormal cervical morphology or function, or history of cervical surgery; refractory vaginitis; multiple pregnancy; concomitant severe medical or surgical diseases; participation in another clinical trial within 90 days prior to randomization, or use of an investigational drug within 30 days; inability to complete long-term follow-up or poor compliance; and any other condition that, in the investigator's judgment, may affect trial implementation or outcome evaluation.","20 Years",{"count":214,"type":23},100,[216],"PHASE4","To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment",[29],"2026-06-08",{"date":221,"type":42},"2026-06-11",{"date":223,"type":42},"2023-04-01",{"date":225,"type":23},"2029-04-30",{"name":227,"class":49},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":60,"phases":238,"briefSummary":241,"conditions":242,"keywords":246,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":131},"100625608","phase-2-xylitol-and-the-prevention-of-periodontal-disease-and-preterm-birth-trial-100625608","NCT07424846","Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial","Xylitol and the Prevention of Periodontal Disease and Preterm Birth (XaPPP) Trial","XaPPP","Inclusion Criteria:\n\n* Able to provide informed consent. For those under 18 years of age, an approval will additionally be sought from the parent or guardian\n* Less than 20 weeks' gestation (by best obstetric estimate)\n* At least 20 natural teeth\n* Planning to deliver at one of the health facilities within the XaPPP trial\n* Receiving antenatal obstetric care at one of the 8 health districts\n* Willing to chew two pieces of gum thrice daily for 5 minutes after the morning, day and evening meals throughout pregnancy\n* Willing to attend all study visits\n* Willing to provide biospecimens (oral, vaginal, placental, breast milk)\n* Willing to undergo at least two dental exams including oral microbiota sampling at study enrolment \\\u003C20 weeks of pregnancy, 28-30 weeks of pregnancy, and 6-8 weeks after giving birth\n* Willing to have their child undergo follow up through at least 12 months after birth including neurodevelopmental examination(s)\n* Speaks Chichewa or English\n\nAll patients who meet inclusion criteria will be approached without regard to sex, race, ethnicity, parents' country of origin, or religious preferences.\n\nExclusion Criteria:\n\n* Those who upon screening and enrolment but dislike the taste of the gum and state they will not chew the gum throughout pregnancy\n* Gravidae with known or suspected non-viable pregnancy (including life threatening congenital anomalies such as cardiac, neurological or others)\n* Pregnant individual has a life-threatening diagnosis such as cancer requiring treatment during pregnancy\n* Pregnant women with a known or suspected morbidly adherent placenta (such as placenta accrete, increta and percreta)\n* Known allergy to xylitol",{"count":237,"type":23},6000,[239,240],"PHASE2","PHASE3","The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum.\n\nWhile PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams\u002Fday more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality.\n\nThe investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \\\u003C20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams\u002Fday), (b) the PPaX trial xylitol dose (2.1 grams\u002Fday), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.",[29,243,31,244,245],"Low Birthweight Neonate","Gingivitis","Developmental Delay",[247,73,248,249,250,251,252],"xylitol","prematurity","pregnancy","periodontitis","periodontal disease","chewing gum","2026-06-05",{"date":255,"type":42},"2026-06-09",{"date":257,"type":42},"2026-03-26",{"date":259,"type":23},"2030-09-30",{"name":261,"class":49},"University of Washington",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":17,"sex":57,"minAge":270,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":60,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":131},"100588268","e-health-supported-diagnostic-and-intervention-in-preterm-born-children-and-their-families-100588268","NCT06939192","E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families","E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach","NeoUp2","Inclusion Criteria:\n\n* Premature babies born at the UKT,\n* Gestational age 28-34 weeks,\n* Mother: age ≥ 18 years,\n* agreement to participate in this study and signing of a consent form,\n* sufficient knowledge of German,\n* internet access\n\nExclusion Criteria:\n\n* Premature babies \\\u003C 28th or \\>34th week of pregnancy,\n* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,\n* at least one of the children has serious congenital diseases or suffers from malformations,\n* Mother: Lack of access to a smartphone\u002Ftablet,\n* no internet access,\n* insufficient knowledge of German","28 Weeks","34 Weeks",{"count":273,"type":23},120,[62],"The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.",[29],[145,278,279,280,281],"E-health","Risk factors","Protective factors","Prevention","2026-06-04",{"date":255,"type":42},{"date":285,"type":42},"2024-01-31",{"date":287,"type":23},"2027-12-31",{"name":289,"class":49},"University Hospital Tuebingen",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":131},"100640988","the-impact-of-image-acquisition-in-cervical-ultrasound-on-ai-based-prediction-of-preterm-birth-in-clinical-practice-100640988","NCT07598097","The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice","The Impact of Image Acquisition in Cervical Ultrasound on AI-Based Prediction of Preterm Birth in Clinical Practice: A Prospective Observational Study","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years\n* Attending routine second-trimester scan (and scheduled transvaginal cervical assessment per local protocol\u002Fworkflow)\n\nExclusion Criteria:\n\n* Absence of transvaginal cervical assessment at the second-trimester scan\n* Missing follow-up data on pregnancy outcome (gestational age at delivery)\n* Inadequate image quality or missing required cervical ultrasound image",{"count":95,"type":23},"This study prospectively evaluates whether the performance of an already-developed artificial intelligence (AI) model for predicting spontaneous preterm birth changes when cervical ultrasound images are obtained using different ultrasound image settings.\n\nThe primary research question is whether the AI model performs differently across images acquired with different imaging settings.",[29,143],[145,146,150,301,302,148,303,304],"Deep learning","Image acquisition","Cervical ultrasound","Prospective validation","2026-05-19",{"date":307,"type":42},"2026-05-20",{"date":309,"type":42},"2026-03-11",{"date":311,"type":23},"2027-02",{"name":157,"class":49},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":60,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":339,"locationsCount":131},"100409686","phase-2-milk-volume-outcomes-following-oral-nicotinamide-riboside-supplementation-in-mothers-of-extremely-preterm-infants-100409686","NCT04614714","Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants","Nicotinamide Riboside and Milk Production in the NICU","MOONRISE","Inclusion criteria are required to be met before or at enrollment:\n\nMothers who are 18 years or older.\n\nInfants delivered at 24-32 weeks OR infants (any GA) that researchers anticipate will be hospitalized in the NICU for at least 4 weeks, including, but not limited to, infants with a diagnosis of gastroschisis, a cardiac defect, intestinal atresia, etc.\n\nInfants born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 7 days of life.\n\nMothers who attempted initial milk expression within 12 hours of delivery.\n\nMothers who attempted milk expression at least 6 times every 24 hours from 72 hours after delivery to the Enrollment Visit.\n\nMothers who have delivered at least 96 hours (4 days) prior to the Enrollment Visit.\n\nMothers who have experienced a level \"3\" on the OMPQ before starting the collection of their first 24-hour pooled milk sample (study days 0-3).\n\nMothers who plan to feed their infants breast milk for at least 3 months.\n\nMothers who were pregnant with one infant.\n\nMothers willing to refrain from tandem feeding (directly breastfeeding) another child during the study period.\n\nMothers willing to refrain from enrolling themselves in another intervention trial during the study period.\n\nMothers willing to express, weigh, record, and collect 24-hour pooled milk\n\nMothers willing to remove nipple piercings during the study period.\n\nMothers willing to refrain from using pseudoephedrine (often found in Sudafed, Theraflu, Claritin-D, etc.) during the study period.\n\nMothers willing to express milk 6 times or more every 24 hours, including at least once during the night, and with no more than 5 hours between milk expression sessions, during the study period.\n\nMothers willing to refrain from consuming non-study supplements that contain nicotinamide-riboside (or similar derivatives, including NMN) during the study period.\n\nMothers willing to refrain from consuming galactagogues during the study period.",{"count":322,"type":23},40,[239,240],"This study aims to evaluate the feasibility and effects of nicotinamide riboside (NR) supplementation in lactating mothers of infants expected to be hospitalized in the neonatal intensive care unit (NICU) for at least four weeks.",[29,326],"Inadequate Milk Production",[328,329,330,331,332],"Nicotinamide Riboside","milk volume","Neonatal intensive care unit","Galactagogue","Feasibility trial","2026-05-14",{"date":335,"type":42},"2026-05-18",{"date":337,"type":23},"2026-06-01",{"date":122,"type":23},{"name":340,"class":49},"University of California, Davis",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":60,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":131},"100456905","stress-phenotypes-and-preterm-birth-100456905","NCT05229666","Stress Phenotypes and Preterm Birth","Stress Phenotypes and Preterm Birth: Immune and Energetic Cellular Dysregulation and the Preventive Effect of Social Support","PTB","Inclusion Criteria\n\n* Pregnant women 18 years of age or older (based on self-report)\n* Not currently smoking, drinking alcohol, or taking drugs (based on self-report)\n* Planning to deliver at CUIMC\u002FNYP (based on self-report)\n* In the first or second trimester of pregnancy (prior to 28 weeks gestation) (based on self-report of estimated date of delivery)\n\nExclusion Criteria\n\n* Multi-fetal pregnancy (based on self-report)\n* Taking medications regularly that affect the cardiovascular and inflammatory systems, including NSAIDS and other anti-inflammatories, α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2- adrenoceptor agonists) (based on self-report)\n\n  * This does NOT include baby aspirin or low-dose aspirin, as baby aspirin \u002F low-dose aspirin is not normally considered to be an NSAID.\n* Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis (based on self-report)",{"count":350,"type":23},200,[62],"Pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women, though more often for Non-Hispanic Black women, 14.12% PTB rate, compared to 9.09% for Non-Hispanic White women. Psychosocial stress and childhood trauma each are associated with risk for PTB and PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. In this project, we will study mitochondria, which contain their own genome, the mitochondria DNA, and are inherited from the mother, as they represent a potential intersection point between psychosocial experiences and their biological embedding in underlying disease outcomes such as PTB",[29,33,178,354],"Mental Health Issue","2026-05-12",{"date":333,"type":42},{"date":358,"type":42},"2021-12-09",{"date":360,"type":23},"2027-12",{"name":362,"class":49},"Columbia University",{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":370,"targetDuration":4,"studyType":60,"phases":372,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":84},"100511885","music-intervention-for-preterm-birth-100511885","NCT05945264","Music Intervention for Preterm Birth","The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women","Inclusion Criteria\n\n* Aged 18 to 40 years\n* Generally healthy pregnant women in the first trimester of pregnancy\n\nExclusion Criteria:\n\n* Non-pregnant women\n* Women with a chronic medical condition that could impact pregnancy health or duration\n* Women regularly taking any medications other than prenatal vitamins",{"count":371,"type":23},142,[62],"This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.",[29],[376,145,377,378,379,380],"Chronic stress","Black women stress","Metabolomics of chronic stress","Music and medicine","Music intervention","2026-05-05",{"date":383,"type":42},"2026-05-07",{"date":385,"type":23},"2026-05-26",{"date":387,"type":23},"2027-08-29",{"name":362,"class":49},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":60,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100640472","bed-rest-with-a-short-cervix-on-preterm-birth-100640472","NCT07577388","Bed Rest With a Short Cervix on Preterm Birth","BEWISE - Bed Rest With a Short Cervix on Preterm Birth","BEWISE","Pregnant women with gestational age 20+0 to 33+6\n\n* Cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies\n* Above 18 years of age\n* Reads and understands Danish or English",{"count":237,"type":23},[62],"Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.\n\nThe use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.\n\nThe overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).\n\nThe primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.\n\nSecondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.\n\nThrough the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \\\u003C 25 mm in singleton pregnancies and \\\u003C 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.\n\nThe primary outcome is gestational age in days (continuous).",[29,185,66,182,401,402,403,404,405,406,407,408,409],"Immobilization","Depression, Postpartum","Pregnancy Outcome","Infant, Premature","Uterine Cervical Incompetence","Premature Birth","Obstetric Labor, Premature","Physical Activity","Bone Density","2026-05-03",{"date":412,"type":42},"2026-05-11",{"date":414,"type":23},"2026-05-01",{"date":416,"type":23},"2029-05-01",{"name":418,"class":49},"Julie Glavind",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":57,"minAge":427,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":60,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":131},"100617205","initial-oxygen-concentration-at-birth-in-late-preterm-infants-100617205","NCT07315594","Initial Oxygen Concentration at Birth in Late-Preterm Infants","Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants","OXY-PREEM","Inclusion Criteria:\n\n* i) Infants with gestational age between 32+0-35+6 weeks based on best available obstetrical estimate, requiring respiratory support\n* ii) Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to provide only comfort care at birth\n* iii) No known major congenital or chromosomal malformation.\n\nExclusion Criteria:\n\n* i) Infant born outside of study centers and transported to centers after delivery.","0 Minutes","10 Minutes",{"count":430,"type":23},1520,[62],"This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth.\n\nIn the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies.",[29],"2026-04-28",{"date":436,"type":42},"2026-05-04",{"date":79,"type":23},{"date":439,"type":23},"2029-12-31",{"name":441,"class":49},"University of Alberta",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":60,"phases":452,"briefSummary":453,"conditions":454,"keywords":463,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100635983","the-root-study-scaling-the-standard-of-care-plus-obstetric-nutrition-model-to-optimize-maternal-and-infant-health-100635983","NCT07559773","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Integrated Model to Optimize Maternal and Infant Health: a Prospective Interventional Study: Resilient Outcomes Through OB-Nutrition Team Care (ROOT)","ROOT","Inclusion Criteria:\n\n* Pregnant women receiving care at NH Triad OB\u002FGYN\n* ≤20 weeks gestational age at enrollment\n* Age ≥ 18 years (\\\u003C18 years requires parental consent)\n* Ability to provide informed consent\n* Access to smart phone\u002Finternet for digital platform use\n\nExclusion Criteria:\n\n* \\> 20 weeks gestational age\n* High-risk pregnancies requiring specialized care beyond study scope\n* Inability to participate in digital health platform\n* Cognitive impairment preventing informed consent",{"count":451,"type":23},500,[62],"The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).\n\nIn 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \\\u003C0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size.\n\nStructured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure.\n\nThe primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics\u002FGynecology (OB\u002FGYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone.\n\nThe secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone.\n\nParticipant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.",[29,174,455,456,457,458,459,460,461,462],"Gestational Diabetes Mellitus (GDM)","Small for Gestational Age (SGA)","Large for Gestational Age (LGA)","Asthma Childhood","Atopic Dermatitis","Autism","Otitis Media Recurrent","Obesity",[464,465,466,467,468,469,470,471,472,473],"adverse pregnancy outcomes","prevention","personalized nutrition","nutrigenomics","adverse neonatal outcomes","childhood asthma","childhood allergy","autism","childhood obesity","recurrent otitis media","2026-04-27",{"date":476,"type":42},"2026-04-30",{"date":478,"type":23},"2026-08",{"date":480,"type":23},"2033-12",{"name":482,"class":49},"GrowBaby Life Project",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":17,"sex":18,"minAge":93,"maxAge":490,"enrollmentInfo":491,"targetDuration":4,"studyType":60,"phases":493,"briefSummary":494,"conditions":495,"keywords":499,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100635484","phase-3-periodontal-disease-and-small-vulnerable-newborns-in-rural-nepal-a-community-based-trial-100635484","NCT07553286","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial","Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Randomized Trial","Inclusion Criteria:\n\n* Married women of reproductive age (15-35 years).\n* Living in the study area who are pregnant and consent to participate.\n\nExclusion Criteria:\n\n* Currently pregnant women.\n* Women who are sterilized or use long-acting contraceptive methods or are divorced or widowed.\n* Women identified as pregnant ≥12 gestational weeks based upon date of last menstrual period.","35 Years",{"count":492,"type":23},2280,[240],"Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and\u002For low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.",[29,496,497,498,27],"Low Birth Weight","Small Vulnerable Newborn","Small-for-gestational Age",[500,501,502,145,503,504,505,28,506,507,244,508,509],"Nepal","Oral health","Small Vulnerable Newborns","Periodontal disease","Low birth weight","Small-for-gestational age","Antenatal care","Dental health","Antiseptic oral rinse","Oral hygiene",{"date":414,"type":42},{"date":79,"type":23},{"date":513,"type":23},"2028-12-31",{"name":515,"class":49},"Johns Hopkins Bloomberg School of Public Health",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":57,"minAge":4,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":527,"conditions":528,"keywords":534,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":553},"100607733","health-related-quality-of-life-and-household-financial-and-wellbeing-impacts-of-prematurity-and-necrotising-enterocolitis-nec-100607733","NCT07192393","Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).","Quantifying the Household Impact on Patient-Reported Outcomes and Costs Associated With the Care of Preterm Babies With and Without Necrotising Enterocolitis (NEC): A Study Alongside the Withholding Enteral Feeds Around Blood Transfusion (WHEAT) Trial","PREM-IMPACT","Inclusion Criteria:\n\n* Preterm birth \\\u003C30 gestational weeks\n\nExclusion Criteria:\n\n* Parent(s) of a preterm baby who died of necrotising enterocolitis (NEC)\n* Parent(s) unwilling or unable to provide written informed consent\n* Parent(s) and sibling(s) unable to understand English.","30 Weeks",{"count":526,"type":23},90,"PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation.\n\nThis study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective.\n\nPREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally.\n\nBy studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.",[529,530,531,532,29,533],"Prematurity; Extreme","Prematurity; Decision Support","Necrotising Enterocolitis","Preterm","Preterm Infant Health",[535,536,537,538,539,540,532,541,542,543],"NEC","Cost-Effectiveness Analysis","Cost-Utility Analysis","Health-Related Quality of Life","HR-QoL","Prematurity","Health Economic Analysis","Financial Impact","Wellbeing","2026-03-27",{"date":546,"type":42},"2026-03-30",{"date":548,"type":42},"2025-08-08",{"date":550,"type":23},"2027-10-31",{"name":552,"class":49},"Imperial College London",7,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":57,"minAge":562,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":60,"phases":566,"briefSummary":567,"conditions":568,"keywords":571,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":131},"100628056","phase-2-caffeine-for-infants-born-at-28-to-34-weeks-receiving-respiratory-support-100628056","NCT07456670","Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support","Caffeine Therapy in Preterm Infants Born at 28-34 Weeks: A Pilot Placebo-Controlled Randomized Controlled Trial","CARES-Pilot","Inclusion Criteria:\n\n* Infant born at a gestational age between 28+0 and 34+6 weeks.\n* Admitted to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of life.\n* Requiring either invasive respiratory support (mechanical ventilation) or non-invasive respiratory support (e.g., CPAP, High Flow Nasal Cannula) within the first 72 hours of life.\n* Informed consent obtained from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Presence of dysmorphic features or major congenital malformations that adversely affect life expectancy.\n* Known or strongly suspected cyanotic heart disease.\n* Infants born at \\\u003C28 weeks' gestational age (due to high risk of apnea requiring routine caffeine).\n* Late preterm infants born at ≥35+0 weeks' gestational age (due to short NICU stay not allowing for a safe caffeine-free period before discharge).","0 Days","28 Days",{"count":565,"type":23},62,[239],"The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing. It will also look at whether caffeine helps these infants get healthy enough to leave the hospital sooner.\n\nThe main questions the researchers aim to answer are:\n\nCan the investigators successfully recruit and keep enough participants in the study? Do the medical teams follow the study drug instructions correctly? Does caffeine reduce the total time infants spend in the Neonatal Intensive Care Unit (NICU)? Researchers will compare caffeine to a placebo (a look-alike substance with no active medicine) to see if caffeine is a helpful treatment for babies born between 28 and 34 weeks of gestation who are using a breathing machine or oxygen.\n\nParticipants will:\n\nBe randomly assigned to receive either caffeine or a placebo through an IV or a feeding tube.\n\nReceive the study treatment once a day as long as they require respiratory support (and for 24 hours after they stop).\n\nBe monitored by the research team for clinical outcomes like feeding progress, breathing stability, and growth until they are discharged from the hospital.",[29,569,570],"Caffeine","Neonatal Outcomes",[569,572,540,573,574,575],"Neonatal Intensive Care Unit","RCT","NICU","Pilot Study","2026-03-06",{"date":578,"type":42},"2026-03-10",{"date":580,"type":23},"2026-04-01",{"date":582,"type":23},"2028-03-31",{"name":584,"class":49},"Queen's University",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":60,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":131},"100579311","optimal-timing-of-routine-cervical-length-measurements-during-anatomy-survey-100579311","NCT06822647","Optimal Timing of Routine Cervical Length Measurements During Anatomy Survey","Inclusion Criteria:\n\n* Pregnant individuals between 16 weeks and 23 weeks + 6 days of gestation.\n* Presenting for a fetal anatomy survey at Henry Ford Health MFM ultrasound units.\n* Consent to a transvaginal cervical length measurement as part of routine care.\n* Agreement to participate in the study, including randomization for the timing of cervical length measurement.\n\nExclusion Criteria:\n\n* History of preterm delivery.\n* Diagnosis of cervical insufficiency.\n* Declines or unable to consent to a transvaginal cervical length measurement.\n* Patients receiving care at non-Henry Ford Health radiology clinics.",{"count":592,"type":23},550,[62],"The goal of this clinical trial is to determine the optimal timing for measuring cervical length (CL) during fetal anatomy surveys in pregnant individuals. This study focuses on improving the accuracy of cervical length assessments, which are critical for identifying individuals at risk for preterm birth. The main questions it aims to answer are:\n\n* Does measuring cervical length at the beginning of the anatomy survey result in a higher proportion of scans meeting the nine CLEAR (Cervical Length Education and Review) criteria compared to measuring at the end of the survey?\n* Does the use of sepia-filtered ultrasound images improve the proportion of scans meeting the nine CLEAR criteria compared to conventional grayscale images?\n\nResearchers will compare two groups of participants randomized to have cervical length measured either at the beginning or at the end of the anatomy survey. Additionally, all participants will undergo cervical length measurements using both grayscale and sepia-filtered ultrasound imaging.\n\nParticipants will:\n\n* Receive a patient information sheet through MyChart explaining the study and standard cervical length screening during anatomy surveys.\n* Provide verbal consent for a transvaginal ultrasound and study participation.\n* Be randomized to have their cervical length measured at either the start or end of the fetal survey.\n* Undergo cervical length measurement using both grayscale and sepia-filtered ultrasound imaging modalities.\n* This study involves no additional risks beyond those of routine clinical care and aims to enhance clinical practice by identifying optimal methods for cervical length assessment during pregnancy.",[185,29,596],"Cervical Length Measurement",{"date":598,"type":42},"2026-03-09",{"date":600,"type":42},"2025-01-20",{"date":602,"type":23},"2027-07-01",{"name":604,"class":49},"Henry Ford Health System",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":60,"phases":615,"briefSummary":616,"conditions":617,"keywords":623,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":635},"100513529","synbiotics-in-patients-at-risk-for-preterm-birth-100513529","NCT05966649","Synbiotics in Patients at RIsk fOr Preterm Birth","Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal","PRIORI","Inclusion Criteria:\n\n1. Signed written informed consent must be obtained before any study assessment is performed;\n2. 18 years of age or older;\n3. Singleton pregnancy;\n4. Pregnancy consultation between 8 and 10 weeks gestation.\n5. At least one of the following risk factors for spontaneous preterm birth:\n\n   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency\n   * PPROM ≤36 weeks in previous pregnancy\n   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.\n\nExclusion Criteria:\n\n1. Patients who are already using pro-, pre- or synbiotics and not willing to stop\n2. Multiple pregnancy\n3. Need for primary (type 1) cerclage\n4. Inflammatory bowel disease\n5. Known congenital uterine anomaly\n6. History of LLETZ conization",{"count":614,"type":23},402,[62],"Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.\n\nPrevious preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.\n\nInfections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).\n\nSynbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.",[618,29,619,620,621,622],"Preterm Spontaneous Labor With Preterm Delivery","Microbial Colonization","Microbiome Dysbiosis","Vaginal Microbiome","Synbiotics",[145,624,625,622],"Vaginal microbiome","Probiotics","2026-02-23",{"date":628,"type":42},"2026-02-27",{"date":630,"type":42},"2023-03-16",{"date":632,"type":23},"2029-06",{"name":634,"class":49},"Ziekenhuis Oost-Limburg",9,{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":57,"minAge":4,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":60,"phases":645,"briefSummary":646,"conditions":647,"keywords":650,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":659,"locationsCount":131},"100514185","continuous-delivery-room-skin-to-skin-study-for-moderate-and-late-preterm-infants-100514185","NCT05975203","Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants","COSY","Inclusion Criteria:\n\n* preterm birth between gestational age of 32 0\u002F7 and 36 6\u002F7 weeks\n* vaginal delivery\n* singleton\n* informed consent before birth\n\nExclusion Criteria:\n\n* malformations or syndromes of the infant\n* resuscitation of the infant\n* maternal psychological or severe physical illness\n* lack of German language skills",{"count":644,"type":23},60,[62],"The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:\n\n* does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?\n* does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?\n\nParticipants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.",[29,648,649],"Mother-Infant Interaction","Infant Development",[651,652],"preterm behavioral epigenetics","skin-to-skin contact","2026-02-18",{"date":655,"type":42},"2026-02-20",{"date":657,"type":42},"2023-08-04",{"date":513,"type":23},{"name":660,"class":49},"University of Cologne",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":60,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":683,"locationsCount":131},"100624856","effectiveness-of-targeted-cervical-length-screening-guided-by-a-preterm-birth-risk-scoring-system-in-reducing-the-rate-of-preterm-birth-100624856","NCT07415070","Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth","Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth: a Cluster Non-randomized Controlled Trial","Inclusion Criteria:\n\n* ·For community health service centers:\n\n  1. Be located in the selected districts\n  2. Provide prenatal care and be responsible for the registration and follow-up management of pregnant women\n  3. Have the chief physician (or equivalent) agree to participate and to implement study-related risk assessment, referral, follow-up, and data collection procedures, and to receive standardized training\n\n     * For pregnant women:\n\n  \u003C!-- -->\n\n  1. Registered at participating community health service centers.\n  2. Singleton pregnancy.\n  3. No history of previous cervical cerclage.\n  4. Able and willing to provide written informed consent and participate in the study.\n\nExclusion Criteria:\n\n* for pregnant women:\n\n  1. Multiple pregnancies.\n  2. History of cervical cerclage.\n  3. Medical indications requiring pregnancy termination.\n  4. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.",{"count":669,"type":23},1000,[62],"This cluster non-randomized controlled trial aims to evaluate the effectiveness and feasibility of a risk score-guided targeted cervical length screening strategy for the prevention of spontaneous preterm birth in routine community-based prenatal care. Pregnant women are first assessed using a simple preterm birth risk scoring system, and those identified as high risk undergo transvaginal cervical length screening followed by guideline-based preventive interventions when clinically indicated.\n\nThe primary objective of the study is to compare this targeted screening strategy with usual prenatal care in reducing the incidence of spontaneous preterm birth occurring between 28 and 36 completed weeks of gestation. Secondary objectives include evaluating the cervical length screening rate, adherence to cervical length screening recommendations, and selected maternal and neonatal outcomes.\n\nResearchers will compare outcomes between women receiving risk score-guided targeted screening and those receiving routine prenatal care without use of the risk scoring system. All participants will be followed until delivery.",[29],[674,675,676],"Cervical length screening","Preterm birth risk score","Maternal and neonatal outcomes","2026-02-14",{"date":679,"type":42},"2026-02-17",{"date":681,"type":23},"2026-03",{"date":360,"type":23},{"name":684,"class":49},"Ningbo University",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":4,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":692,"targetDuration":4,"studyType":60,"phases":694,"briefSummary":695,"conditions":696,"keywords":699,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":84},"100546525","phase-4-improvement-of-pprom-management-with-prophylactic-antimicrobial-therapy-iprompt-100546525","NCT06396078","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy","Inclusion criteria\n\n* Admitted to the inpatient unit for expectant management of PPROM until delivery\n* Age ≥ 18 years with the ability to provide informed consent\n* Gestational age between 23 0\u002F7 and 32 6\u002F7 weeks\n\nExclusion criteria\n\n* Having received more than one dose of any prophylactic antibiotic\n* Suspected or confirmed infection requiring treatment with antibiotics\n* Allergy or contraindication to an antibiotic in either arm\n* Maternal immunosuppression",{"count":693,"type":23},56,[216],"To conduct an unblinded pragmatic randomized controlled trial (pRCT) \"Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)\" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin\u002Famoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \\\u003C34 weeks.",[697,698,29],"Preterm Premature Rupture of Membrane","Pregnancy, High Risk",[28,700,701,702,703],"Preterm premature rupture of membranes","Latency","Chorioamnionitis","Antibiotic prophylaxis","2026-01-23",{"date":706,"type":42},"2026-01-27",{"date":708,"type":42},"2024-07-18",{"date":710,"type":23},"2026-12",{"name":712,"class":49},"Ohio State University",{"id":714,"slug":715,"hasResults":12,"nctId":716,"briefTitle":717,"officialTitle":718,"acronym":719,"eligibilityCriteria":720,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":721,"enrollmentInfo":722,"targetDuration":4,"studyType":60,"phases":724,"briefSummary":725,"conditions":726,"keywords":729,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":743,"lastUpdatePostDateStruct":744,"startDateStruct":746,"completionDateStruct":748,"leadSponsor":750,"locationsCount":553},"100571679","phase-3-asymptomatic-bacteriuria-in-pregnancy-in-low--and-middle-income-countries-100571679","NCT06723392","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research","ABLE","Inclusion Criteria:\n\nIndividuals who meet the following criteria are eligible for randomization:\n\n* Enrolled in GN MNHR\n* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and\u002For clinical assessment and\u002For ultrasonography\n* Age: 18 years (or lower limit age eligible\\*) to 49 years\n\n  \\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.\n* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up\n* Able to provide informed consent\n* Presence of a single bacterial isolate (\\>105 colony forming unit (CFU)\u002FmL) in urine at enrollment\n* Intent to remain in study area for at least 42 days PP\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for randomization:\n\n* Gestational age \\\u003C12 weeks or \\>20 weeks\n* Received treatment with any antibiotic within 14 days before screening visit\n* Current symptoms of UTI\n* History of allergy to nitrofurantoin\n* Pregnancy loss \u002F miscarriage prior to randomization\n* Currently taking magnesium-containing antacid\n* Any illness \u002F condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment\n* Enrollment in another trial that per the study MOP will impact this trial","49 Years",{"count":723,"type":23},1134,[240],"This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \\[End preventable deaths of newborns and children under 5 years of age\\] by examining the potential impact of this practice to reduce the incidence of SVN\u002FSB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).",[29,456,727,728],"Stillbirth","Bacteriuria (Asymptomatic) in Pregnancy",[730,731,73,732,733,734,735,736,737,738,739,740,741,742],"asymptomatic bacteriuria","small vulnerable newborn","small for gestational agea","still birth","SVN\u002FSB","oral nitrofurantoin monohydrate\u002Fmacrocrystals","Global Network","Bangladesh","India","Pakistan","Democratic Republic of Congo","Zambia","Guatemala","2026-01-20",{"date":745,"type":42},"2026-01-22",{"date":747,"type":42},"2025-12-08",{"date":749,"type":23},"2028-11",{"name":751,"class":752},"NICHD Global Network for Women's and Children's Health","NETWORK",{"id":754,"slug":755,"hasResults":12,"nctId":756,"briefTitle":757,"officialTitle":758,"acronym":4,"eligibilityCriteria":759,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":760,"targetDuration":4,"studyType":60,"phases":762,"briefSummary":763,"conditions":764,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":766,"lastUpdatePostDateStruct":767,"startDateStruct":769,"completionDateStruct":771,"leadSponsor":773,"locationsCount":775},"100543970","effect-of-support-for-low-income-mothers-of-preterm-infants-100543970","NCT06362798","Effect of Support for Low-Income Mothers of Preterm Infants","Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)","Inclusion Criteria:\n\n* Mother is eligible for Medicaid insurance.\n* Has an infant or infants born 24 0\u002F7-34 1\u002F7 weeks gestation.\n* Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.\n* Mother is eligible to breastfeed (per hospital criteria).\n\nExclusion Criteria:\n\n* Mother is not English- or Spanish-speaking.",{"count":761,"type":23},420,[62],"Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). We received supplemental funding to extend analyses to include extended postpartum maternal health outcomes. The original sample size of 420 remains the basis for the parent trial's primary and secondary NICU caregiving outcomes, while the supplemental funding (effective January 2026) enables analysis of secondary maternal health outcomes up to 12 months postpartum using an expanded analytic cohort. The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.",[29,765],"Low; Birthweight, Extremely (999 Grams or Less)","2026-01-06",{"date":768,"type":42},"2026-01-08",{"date":770,"type":42},"2024-10-24",{"date":772,"type":23},"2028-08-31",{"name":774,"class":49},"University of Massachusetts, Worcester",4]