[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm-delivery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm-delivery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100591407","phase-3-aspirin-dose-escalation-for-the-prevention-of-recurrent-preterm-delivery-trial-100591407",false,"NCT06980025","Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial","A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth","ADEPT","Inclusion Criteria:\n\n* 14 years or older\n* Singleton gestation. Twin gestation reduced to a singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher-order multifetal gestations reduced to singletons are not eligible.\n* Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.\n* Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater:\n\n  * Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes\n  * Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically.\n  * Stillbirth excluding those with known genetic disorders or major congenital anomalies.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day)\n* Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin\n* Thrombocytopenia defined as a platelet count defined as a platelet count \\\u003C100,000 microliters\n* Gastric bypass surgery, regardless of type\n* Aspirin use \\>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization.\n* Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery.\n* Known fetal genetic disease or major malformations\n* Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion.\n* Any fetal\u002Fmaternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.\n* Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth:\n\n  * Treated hypertension requiring more than one agent\n  * Chronic renal disease with baseline serum creatinine ≥1.5 mg\u002FdL\n  * Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus)\n  * Uncontrolled hyper- and hypothyroid disease\n  * New York Heart Association (NYHA) stage II or greater cardiac disease\n* Planned indicated delivery prior to 37 weeks.\n* Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery).\n* Participation in this trial in a previous pregnancy.\n* Delivery planned at a non-participating site",true,"FEMALE","14 Years",{"count":21,"type":22},1800,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.",[28,29],"Preterm Delivery","Obstetrical Complications",[28,31,32,33,34],"Stillbirth","Maternal Morbidity","Neonatal Morbidity","Prevention","RECRUITING","2026-04-03",{"date":38,"type":39},"2026-04-09","ACTUAL",{"date":41,"type":39},"2025-07-01",{"date":43,"type":22},"2029-02-28",{"name":45,"class":46},"The George Washington University Biostatistics Center","OTHER",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"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","18 Years",{"count":57,"type":22},60,[59],"NA","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.",[28,62,63],"Cervical Cerclage","Cervical Insufficiency","NOT_YET_RECRUITING","2026-04-02",{"date":67,"type":39},"2026-04-08",{"date":69,"type":22},"2026-05-01",{"date":71,"type":22},"2028-05-01",{"name":73,"class":46},"Kaplan Medical Center",4,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100616573","evaluation-of-the-clinical-performance-of-the-premasure-kit-to-assess-premature-delivery-risk-in-symptomatic-pregnant-patients-100616573","NCT07307365","Evaluation of the Clinical Performance of the PremaSure Kit to Assess Premature Delivery Risk in Symptomatic Pregnant Patients","Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* Female patients above 18 years\n* Gestational week from 22w+0 days to 35w+6 days\n* Symptoms of prematurity.\n\nExclusion Criteria:\n\n* Subject lacking capacity to provide informed consent\n* Enrolment of the project leader, their family members, employees and other dependent persons\n* Patients with ruptured amniotic membranes or blood in their vaginal discharge\n* Patients with vaginal examination in the last 24 hours\n* Previous enrolment in the current study",{"count":82,"type":22},800,"3 Months","OBSERVATIONAL","The goal of the study is to determine the clinical performance of the PremaSure kit, more precisely to assess whether the PremaSure kit can be used as a self-test to assess the risk of premature delivery in patients showing symptoms of premature delivery. The sensitivity and specificity of the test will be determined using as an outcome the delivery of the patient in the 7\u002F14 days following the test.\n\nThe simplified procedure is the following:\n\n1. Patients are recruited and screened for eligibility criteria\n2. A healthcare professional collects a vaginal swab from the patient\n3. The collected sample is tested on the PremaSure kit\n4. Pregnancy outcome is compared to the PremaSure kit's result",[28],[28,88],"Self-test","2025-12-15",{"date":91,"type":39},"2025-12-29",{"date":93,"type":39},"2025-12-05",{"date":95,"type":22},"2027-03",{"name":97,"class":98},"Rea Diagnostics SA","INDUSTRY",1]