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.

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.

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Key information

Conditions

Premature Rupture of Membranes at Term Mode of Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mode of delivery, maternal and neonatal outcomes/complications

Other

Mode of delivery, maternal and neonatal outcomes/complications

Primary outcomes

mode of delivery (vaginal delivery or cesarean)

Time frame: 1 day

mode of delivery (vaginal delivery or cesarean)

Secondary outcomes

maternal and fetal outcomes

Time frame: 1 day

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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Sep 25, 2020
Registry last updated: Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed