Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes

Study Overview
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Brief Summary
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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. Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term. The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.

Official Title
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Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes

Conditions
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Premature Rupture of Membranes at Term, Mode of Delivery

Intervention / Treatment
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* Other: Mode of delivery, maternal and neonatal outcomes/complications


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Singleton Pregnancy >37 weeks of gestation Premature Rupture Of Membranes Cephalic presentation Unfavorable cervix (BISHOP <7) No contraindication of induction methods Exclusion criteria: Multiple gestation PROM with spontaneous labor Induction of labor with both methods Previous cesarean section Unexplained metrorrhagia / Placenta praaevia Suspected intraamniotic infection Herpes simplex virus Human immunodeficiency virus Any contraindication to vaginal delivery Latex allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induction of labor with Foley catheter<br>Induction of labor with Foley catheter | |
| Induction of labor with Propess<br>Induction of labor with Propess | Other: Mode of delivery, maternal and neonatal outcomes/complications<br>* Mode of delivery, maternal and neonatal outcomes/complications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mode of delivery (vaginal delivery or cesarean) | mode of delivery (vaginal delivery or cesarean) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal and fetal outcomes | looking for maternal complications (endometritis, chorioamniotitis, transfusion, post-partum hemorrhage) and neonatal complications (sepsis, apgar<7 at 5minutes, pH <7,15, neonatal intensive care unit) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications and outcomes maternal and neonatal, Induction of labor, Prostaglandins, Foley Catheter