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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04565340

Enrollment

188

Registered

2020-09-25

Start date

2020-03-01

Completion date

2020-08-01

Last updated

2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mode of Delivery, Premature Rupture of Membranes at Term

Keywords

Complications and outcomes maternal and neonatal, Induction of labor, Prostaglandins, Foley Catheter

Brief summary

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.

Interventions

OTHERMode of delivery, maternal and neonatal outcomes/complications

Mode of delivery, maternal and neonatal outcomes/complications

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
mode of delivery (vaginal delivery or cesarean)	1 day	mode of delivery (vaginal delivery or cesarean)

Secondary

Measure	Time frame	Description
maternal and fetal outcomes	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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026