[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pprom\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pprom":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,72,107,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643878","phase-4-extended-azithromycin-treatment-in-prelabor-rupture-of-membranes-100643878",false,"NCT07669207","Extended Azithromycin Treatment in Prelabor Rupture of Membranes","Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study","Inclusion Criteria:\n\n* Singleton gestation\n* Gestational age at time of PPROM between 22w0d and 28w0d\n* Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)\n* Remain pregnant 48 hours after presentation.\n* Patients who receive betamethasone, magnesium therapy, and\u002For a limited course of tocolysis (through the betamethasone window) will be included.\n* Pregnant patients below the age of 18 are eligible.\n\nExclusion Criteria:\n\n* Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)\n* Lethal congenital defects\n* Multiple gestation\n* Ongoing alternative antibiotic treatment\n* Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic\n* History of cholestatic jaundice\u002Fhepatic dysfunction associated with prior use of azithromycin\n* Known prolongation of QT interval\n* History of torsades de pointes\n* Congenital long QT syndrome\n* Bradyarrhythmia\n* Decompensated heart failure\n* Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents\n* Impaired hepatic function\n* GFR\\\u003C10 mL\u002Fmin\n* Diagnosis of myasthenia gravis","FEMALE",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.\n\nResearchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.\n\nParticipants will:\n\n* Be randomly assigned to one of two groups:\n* The standard antibiotic treatment\n* The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.\n* Participants will be asked to complete a survey regarding their experience and side effects.",[25,26],"Preterm Prelabor Rupture of Membranes","PPROM",[28,29],"azithromycin","peri-viability","NOT_YET_RECRUITING","2026-06-21",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":19},"2026-07-01",{"date":38,"type":19},"2028-07",{"name":40,"class":41},"Alexa Henderson","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100498650","digital-vs-speculum-exams-for-pprom-100498650","NCT05773014","Digital vs. Speculum Exams for PPROM","Digital Versus Speculum Exams in Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial","MOCA","Inclusion Criteria:\n\n* 22 weeks 0 days gestation to 33 weeks 5 days gestation\n* Clinical or laboratory confirmation of PPROM\n* At least 8 hours after rupture event\n* English speaking\n\nNotably, for patients \\\u003C25 weeks, approach for enrollment will be deferred until after the patient has discussed their desires for fetal resuscitation with the care team and are at a gestational age where they would desire this resuscitation.\n\nExclusion Criteria:\n\n* Contraindications to digital examination\n* COVID-19 positive on admission",true,{"count":53,"type":19},86,[55],"NA","After preterm prelabor rupture of membranes (PPROM)\\[breaking of the amniotic sac prior to 37 weeks gestation in pregnancy\\], patients are recommended for inpatient admission and close monitoring for complications including preterm labor, intraamniotic infection (infection of the sac around the baby), and placental abruption (separation of the placenta from wall of the uterus). When evaluation of cervical dilation is clinically indicated, obstetricians traditionally perform sterile speculum exams due to concern for decrease in pregnancy latency (length of time between breaking the water and delivery) with sterile digital exams in retrospective studies. These studies are concerning, however, by the indications for the exams and are at risk for confounding by indication. This is a randomized, non-inferiority trial to examine if sterile digital versus speculum exams effect latency of pregnancy in patients with PPROM.",[26],[26,59,60,61],"speculum exam","preterm birth","preterm prelabor rupture of membranes","RECRUITING","2025-12-29",{"date":65,"type":34},"2026-01-05",{"date":67,"type":34},"2023-03-27",{"date":69,"type":19},"2027-07-01",{"name":71,"class":41},"Washington University School of Medicine",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":20,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100607654","antenatal-breastmilk-expression-in-pregnant-women-at-high-risk-of-preterm-birth-100607654","NCT07191366","Antenatal Breastmilk Expression in Pregnant Women at High Risk of Preterm Birth","EXPRESSMOM2 in Pregnant Women at High Risk of Preterm Birth. Aspects of Antenatal Breastmilk Expression and Safety From Gestational Week 28-34 and Potential Nutritional Benefits for the Newborn Infant.","EXPRESSMOM2","Inclusion Criteria:\n\n* Pregnant women with a GA between 28 weeks and 0 days and 34 weeks and 0 days who are either diagnosed with preeclampsia or PPROM or have previously given birth before 34 weeks of gestation\n* Resident in the Region of Southern Denmark\n* Women speaking and understanding Danish or English\n* Planning to breastfeed their infants\n\nExclusion Criteria:\n\n* HELLP or severe preeclampsia indicating expected induction of labour\u002Fcaesarean section within a few days (According to national guidelines)\n* Chorioamnionitis indicating induction of labour\u002Fcaesarean section within a few days\n* Women with a vaginal cerclage and PPROM\n* Women taking medications contraindicating breastfeeding\n* Women with prior breast reductive surgery or mastectomy\n* Below 18 years of age\n* Contractions to a certain extend expecting delivery within a few days\n* Included in other trials, where breastfeeding is among outcomes","18 Years",{"count":82,"type":19},250,[55],"In this randomized controlled study, the investigators aim to examine if antenatal breastmilk expression (aBME) from week 28 in high-risk pregnancies is a safe and effective method to ensure early access to mother's own milk.\n\nIn addition, this study will analyze and compare colostrum from pregnancy with colostrum after birth, investigates women's confidence in breastfeeding and breastfeeding establishment as well as measures oxytocin levels during aBME and active labour with no aBME.",[86,26,87,88],"Preterm Birth","Preeclampsia","Previous Preterm Birth",[90,91,92,26,87,93,94,95,96,97],"Antenatal breastmilk expression","ABME","Preterm birth","Previous preterm birth","Colostrum","Colostrum analysis","Safety","self-efficacy","2025-09-17",{"date":100,"type":34},"2025-09-24",{"date":102,"type":19},"2026-09",{"date":104,"type":19},"2029-07",{"name":106,"class":41},"Odense University Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":20,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":42},"100590256","vaginal-probiotics-during-pregnancy-after-premature-24-32-weeks-of-gestation-preterm-rupture-of-membranes-100590256","NCT06965049","Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes","Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)","PROB-PROM","Inclusion Criteria:\n\n* women ≥ 18 years of age;\n* mono-fetal pregnancy;\n* treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and \\\u003C 7 days in one of the study centers with expectant management;\n* speaking and able to read French or English.\n\nExclusion Criteria:\n\n* Presence of active labor;\n* Situation contraindicating expectant management (e.g., infection);\n* Significant malformation, chromosomal anomaly, or fetal death;\n* Signs of fetal distress;\n* Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;\n* Allergy to soy or lactose;\n* Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);\n* Vaginal probiotics intake 15 days before study inclusion;\n* Oral probiotic intake 30 days before study inclusion.",{"count":116,"type":19},80,[55],"The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).\n\nSecondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.\n\nTo achieve this, participants will be asked to:\n\n* Use the vaginal study product from the time of membrane rupture until delivery\n* Keep a diary documenting their symptoms and treatment adherence\n* Provide vaginal secretion samples and stool samples from their baby",[120,121,26],"Pregnancy","Prematurity",[123,124,26,125,126],"pregnancy","prematurity","vaginal probiotics","microbiota","2025-05-01",{"date":129,"type":34},"2025-05-11",{"date":131,"type":19},"2025-09-01",{"date":133,"type":19},"2026-05",{"name":135,"class":41},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":20,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100585775","preterm-rupture-of-membranes-optimising-antibiotics-trial-100585775","NCT06906757","Preterm Rupture of Membranes Optimising Antibiotics Trial","Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.","PROMOAT","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nPregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.\n\nPROMOAT-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all PROMOAT-specific inclusion criteria:\n\n1. Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) \\\u003C 37+0 weeks' gestation as determined by the treating clinician and standard criteria:\n\n   * Maternal history consistent with loss of fluid per vagina\n   * Evidence of a pool of fluid in the vagina on sterile speculum examination\n   * +\u002F- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND\n2. Are eligible for at least two treatment arms within the domain\n3. The fetus\u002Ffetuses are alive at randomisation\n4. The pregnancy is continuing and active neonatal management is planned.\n\nParticipants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves OR\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nParticipants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:\n\n1. Antibiotic treatment for \\> 24 hours administered with the aim of preventing infection from PPROM\n2. Suspected maternal or fetal infection (chorioamnionitis)\n3. Maternal or fetal indication for immediate birth\n4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)\n5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection\u002Fs\n6. Women with a previous infant affected by GBS sepsis\n7. Major congenital fetal anomaly.\n\nPlatform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.",{"count":145,"type":19},3900,[55],"The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.\n\nPROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \\\u003C 37+0 weeks' gestation.\n\nResearchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.\n\nParticipants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.\n\nNeonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.\n\nQuestionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[26,149],"Preterm",[151,152],"Pregnancy, Preterm, PPROM, Antibiotics","chorioamnionitis","2025-03-31",{"date":155,"type":34},"2025-04-02",{"date":157,"type":19},"2025-09",{"date":159,"type":19},"2050-12",{"name":161,"class":41},"University of Melbourne"]