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

September 21, 2020 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with Premature Rupture Of Membranes at term (>37SA) at Montpellier University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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