[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-insufficiency":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,66,92,124,147,169],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":49,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100586442","personalized-care-for-prenatal-stress-reduction--prevention-of-preterm-birth-ptb-disparities-100586442",false,"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.","FEMALE","18 Years",{"count":20,"type":21},1228,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Preterm Birth Complication","Preterm Birth","Preterm Birth Recurrence","Preeclampsia","Preeclampsia (PE)","Hypertensive Disorders of Pregnancy","Support Program","Stress","Resilience, Psychological","Empowerment, Patient","Emotional Stress","Pregnancy","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",[15,50,51,52],"pregnancy-related disparities","patient support program","enhanced prenatal care","NOT_YET_RECRUITING","2026-06-25",{"date":56,"type":57},"2026-06-29","ACTUAL",{"date":59,"type":21},"2026-08-01",{"date":61,"type":21},"2029-01",{"name":63,"class":64},"University of North Carolina, Chapel Hill","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100639514","phase-4-azithromycin-for-cerclage-prophylaxis-100639514","NCT07608562","Azithromycin for Cerclage Prophylaxis","Evaluating Azithromycin Prophylaxis and Mycoplasma Prevalence in High-Risk Pregnancies Requiring Cerclage: A Prospective Cohort Study","Inclusion Criteria:\n\n* Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment\n* Indication for transvaginal cerclage placement\n* Intact amniotic membranes\n\nExclusion Criteria:\n\n* Evidence of active infection or chorioamnionitis at presentation\n* Preterm prelabor rupture of membranes (PPROM)\n* Multiple gestation\n* HIV positive status\n* Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)\n* Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)\n* Major fetal anomaly or known chromosomal abnormalities that significantly affect viability\n* Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage",{"count":74,"type":21},80,[76],"PHASE4","The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.",[42],[80,81,82],"short cervix","pregnancy prolongation","cerclage","2026-06-24",{"date":54,"type":57},{"date":86,"type":21},"2026-08",{"date":88,"type":21},"2028-12",{"name":90,"class":64},"Wake Forest University Health Sciences",2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"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":101,"type":21},6000,[24],"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).",[28,42,105,39,106,107,108,109,110,111,112,113,114],"Bed Rest","Immobilization","Depression, Postpartum","Pregnancy Outcome","Infant, Premature","Uterine Cervical Incompetence","Premature Birth","Obstetric Labor, Premature","Physical Activity","Bone Density","2026-05-03",{"date":117,"type":57},"2026-05-11",{"date":119,"type":21},"2026-05-01",{"date":121,"type":21},"2029-05-01",{"name":123,"class":64},"Julie Glavind",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100630761","use-of-nitrous-oxide-for-pain-and-anxiety-management-during-cervical-cerclage-removal-100630761","NCT07491874","Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal","Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Women at ≥34 weeks of gestation\n* Singleton or twin pregnancy\n* Ability to understand, sign informed consent, and complete questionnaires\n\nExclusion Criteria:\n\n* Triplet or higher-order pregnancy\n* Contraindications to nitrous oxide use\n* Fetal monitoring category 2 or higher\n* Maternal body temperature \\>38°C\n* Significant vaginal bleeding\n* Severe preeclampsia\n* Cerclage removal under general anesthesia\n* Language or cognitive barrier\n* Baseline pain \\>3 on VAS scale, prior to the procedure",{"count":132,"type":21},60,[24],"The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.\n\nThe study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.\n\nThe main questions the study aims to answer are:\n\n* Does inhaled nitrous oxide reduce pain during cervical cerclage removal?\n* Does inhaled nitrous oxide reduce anxiety during the procedure?\n* Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?\n\nResearchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.\n\nParticipants will:\n\n* Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide \u002F 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.\n* Undergo the procedure according to routine clinical practice in the participating centers.\n* Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).\n* Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.",[136,137,42],"Preterm Delivery","Cervical Cerclage","2026-04-02",{"date":140,"type":57},"2026-04-08",{"date":119,"type":21},{"date":143,"type":21},"2028-05-01",{"name":145,"class":64},"Kaplan Medical Center",4,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":65},"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":154,"type":21},550,[24],"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.",[42,28,158],"Cervical Length Measurement","RECRUITING","2026-03-06",{"date":162,"type":57},"2026-03-09",{"date":164,"type":57},"2025-01-20",{"date":166,"type":21},"2027-07-01",{"name":168,"class":64},"Henry Ford Health System",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":159,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":91},"100525497","nordic-randomized-trial-on-laparoscopic-versus-vaginal-cerclage-100525497","NCT06122506","Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage","NORACT","Inclusion Criteria:\n\n* Women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth.\n* Not yet pregnant or \\\u003C10 weeks' pregnant.\n\nExclusion Criteria:\n\n* Any circumstance under which the clinician is not willing to randomize is an exclusion criterion.\n* Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks).\n* Language difficulties.",{"count":177,"type":21},188,[24],"Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy.\n\nTo evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England",[28,42],[82],"2024-12-05",{"date":184,"type":57},"2024-12-10",{"date":186,"type":57},"2024-01-31",{"date":188,"type":21},"2028-03",{"name":190,"class":64},"University of Aarhus"]