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

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT04565340
• Collaborator: (none)
• Enrollment: 188
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 37.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Rupture of Membranes at Term; Mode of Delivery	Other: Mode of delivery, maternal and neonatal outcomes/complications

Study Design

• Study Type: Observational
• Actual Enrollment: 188 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Induction of labor with Foley catheter Induction of labor with Foley catheter
Induction of labor with Propess Induction of labor with Propess	Other: Mode of delivery, maternal and neonatal outcomes/complications; Mode of delivery, maternal and neonatal outcomes/complications

Outcome Measures

Primary Outcome Measures

1. mode of delivery (vaginal delivery or cesarean) [1 day]

   mode of delivery (vaginal delivery or cesarean)

Secondary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Study Director: Florent FUCHS, PUPH, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04565340
• Other Study ID Numbers: RECHMPL20_0143
• First Posted: Sep 25, 2020
• Last Update Posted: Sep 25, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Complications and outcomes maternal and neonatal; Induction of labor; Prostaglandins; Foley Catheter
• Additional relevant MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture

Study Results

No Results Posted as of Sep 25, 2020