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

NCT ID: NCT04565340

Last Updated: 2020-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-08-01

Brief Summary

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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

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Conditions

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Premature Rupture of Membranes at Term Mode of Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Induction of labor with Foley catheter

Induction of labor with Foley catheter

No interventions assigned to this group

Induction of labor with Propess

Induction of labor with Propess

Mode of delivery, maternal and neonatal outcomes/complications

Intervention Type OTHER

Mode of delivery, maternal and neonatal outcomes/complications

Interventions

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Mode of delivery, maternal and neonatal outcomes/complications

Mode of delivery, maternal and neonatal outcomes/complications

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent FUCHS, PUPH

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0143

Identifier Type: -

Identifier Source: org_study_id

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