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

Completed

• Conditions: Premature Rupture of Membranes at Term; Mode of Delivery
• Interventions: Other: Mode of delivery, maternal and neonatal outcomes/complications

• Registration Number: NCT04565340
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-08-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Induction of labor with Propess	Mode of delivery, maternal and neonatal outcomes/complications	Induction of labor with Propess

Primary Outcome Measures

Name	Time	Method
mode of delivery (vaginal delivery or cesarean)	1 day	mode of delivery (vaginal delivery or cesarean)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France