Clinical trials: Rupture of Membranes; Premature
Fetal Growth Restriction (FGR), Preterm Birth
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Pregnancy complications such as pre-eclampsia (high blood pressure during pregnancy), poor fetal growth, unexplained stillbirth, and spontaneous preterm birth are major causes of illness and death for mothers and babies in…
- Conditions
- Fetal Growth Restriction (FGR), Preterm Birth, Still Births, Abruptio Placentae
- Trial name
- EPAPOA (NCT07844876)
- Where
- 2 sites in Uganda
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Makerere University
Pregnancy, Prematurity
Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT). Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across…
- Conditions
- Pregnancy, Prematurity, PPROM
- Trial name
- PROB-PROM (NCT06965049)
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Premature Rupture of Membranes at Term, Mode of Delivery
Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.
- Trial name
- NCT04565340
- Testing
- Mode of delivery, maternal and neonatal outcomes/complications
- Where
- France
- Volunteers
- 188 people
- Sponsor
- University Hospital, Montpellier
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
The AMNIO-BRAIN Trial is a research study looking at whether a simple treatment during labor can help protect a baby's brain. Some newborns develop a condition called hypoxic-ischemic encephalopathy (HIE), which happens when the…
- Conditions
- Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion, Neonatal Brain Injury
- Trial name
- AMNIO-BRAIN (NCT07610642)
- Testing
- Intrauterine Pressure Catheter, Standard obstetric care at discretion of delivery provider
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medical College of Wisconsin
Premature Rupture of Membranes at Term
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.
- Trial name
- NCT00355966
- Testing
- Misoprostol, PGE2 gel
- Where
- India
- Volunteers
- 212 people
- Sponsor
- Nilratan Sircar Medical College
Premature Birth
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.
- Trial name
- ACSinPROM (NCT02469519)
- Testing
- Betamethasone - ACTIVE
- Where
- 9 sites in United States
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Pediatrix
Pregnancy, Premature Rupture of Membranes
Cervical Ripening in Premature Rupture of Membranes
Premature rupture of membranes (PROM) is diagnosed by demonstrating amniotic fluid in the vaginal canal before the onset of labor.
- Conditions
- Pregnancy, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes, Unfavorable Cervix
- Trial name
- NCT02314728
- Testing
- Misoprostol, Oxytocin
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Preterm Premature Rupture of Membrane
mtDNA as Novel Biomarker for Intra-amniotic Infection
Finding a predictive biomarker for IAI could improve the clinical outcome for the mother and the neonate. The aim of this study is to quantify the copy number of circulating cell-free mitochondrial DNA in maternal serum and the…
- Trial name
- mtDNA (NCT03306719)
- Testing
- Blood sampling
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Premature Rupture of Membranes
FOLCROM Trial: Foley Catheter in Rupture of Membranes
Multicenter randomized clinical trial comparing oxytocin versus oxytocin and foley catheter for induction in women who present with premature rupture of membranes who are not in labor.
- Trial name
- FOLCROM (NCT01973036)
- Testing
- Foley Catheter, Oxytocin
- Where
- 5 sites in United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM)
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
Pregnancy is a physiological process; however, it is also a dynamic period during which obstetric and medical complications that may threaten maternal and fetal health can occur.
- Conditions
- Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM), High-Risk Pregnancy
- Trial name
- NCT07559071
- Testing
- Emotional Freedom Technique (EFT), Music Therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 177 people
- Sponsor
- Selcuk University
Oligohydramnios
Amnioinfusion Initiative
The aim of this study is to compare perinatal survival in patients presenting with early spontaneous PPROM and persistent oligohydramnios, managed either conservatively or with serial amnioinfusions.
- Trial name
- NCT00787163
- Testing
- amnioinfusion
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Università degli Studi di Brescia
Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn
PROMMO Trial: Oral Misoprostol vs IV Oxytocin
This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score.
- Trial name
- PROMMO (NCT04478942)
- Testing
- Misoprostol Oral Product, Intravenous Oxytocin
- Where
- United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Cardiotocography, Premature Rupture of Membrane
Computerized Cardiotocography Monitoring of Fetuses With pPROM
Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome.
- Conditions
- Cardiotocography, Premature Rupture of Membrane, Rupture of Membranes; Premature, Sepsis
- Trial name
- COCA-PROM (NCT04632017)
- Testing
- Computerized cardiotocography
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- University of Campania Luigi Vanvitelli
Preterm Premature Rupture of Membrane, Pregnancy, High Risk
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
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…
- Conditions
- Preterm Premature Rupture of Membrane, Pregnancy, High Risk, Preterm Birth
- Trial name
- NCT06396078
- Testing
- Ceftriaxone 1000 MG, Clarithromycin 500mg, Metronidazole 500 mg
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Ohio State University
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Preterm Premature Rupture of Fetal Membranes
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay
The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for…
- Trial name
- NCT01637610
- Where
- Canada
- Volunteers
- 85 people
- Sponsor
- University of Saskatchewan
Premature Rupture of Membrane
Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes
The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis
- Trial name
- NCT02819570
- Testing
- I.V cefuroxime 750 mg*3/d for 2 days, I.V ampicillin 2 gram x4/d for 2 days, P.O cefuroxime 500 mgx2/d for 5 days
- Where
- Israel
- Volunteers
- 400 people
- Sponsor
- Western Galilee Hospital-Nahariya
Pregnancy Related, Remote Monitoring
Feasibility of Remote eCTG Monitoring Home@Hospital in Complicated Pregnancies
The objective of this single center, interventional cohort study is to evaluate the feasibility of remote electrophysiological cardiotocography (eCTG) monitoring in complicated pregnancies in a home@hospital setting.
- Conditions
- Pregnancy Related, Remote Monitoring, Feasibility
- Trial name
- HASTA (NCT06859177)
- Testing
- Remote eCTG
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Maxima Medical Center
Chorioamnionitis Affecting Fetus or Newborn
Chorioamnionitis and Proinflammatory S100A12
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.
- Trial name
- S100A12 (NCT02996279)
- Volunteers
- 69 people
- Sponsor
- Catholic University of the Sacred Heart
Premature Rupture of Fetal Membranes, Labor, Induced
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM).
- Conditions
- Premature Rupture of Fetal Membranes, Labor, Induced, Cervical Ripening
- Trial name
- POXY-PROM (NCT07366359)
- Testing
- Sequential Induction: Dinoprostone Followed by Oxytocin, Immediate Oxytocin Induction
- Where
- Vietnam
- Volunteers
- 450 people
- Sponsor
- National Hospital of Obstetrics and Gynecology