NCT04565340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

29 days

First QC Date

September 14, 2020

Last Update Submit

September 21, 2020

Conditions

Premature Rupture of Membranes at TermMode of Delivery

Keywords

Complications and outcomes maternal and neonatalInduction of laborProstaglandinsFoley Catheter

Outcome Measures

Primary Outcomes (1)

  • mode of delivery (vaginal delivery or cesarean)

    mode of delivery (vaginal delivery or cesarean)

    1 day

Secondary Outcomes (1)

  • maternal and fetal outcomes

    1 day

Study Arms (2)

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

Interventions

Mode of delivery, maternal and neonatal outcomes/complicationsOTHER

Mode of delivery, maternal and neonatal outcomes/complications

Induction of labor with Propess

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Singleton Pregnancy \>37 weeks of gestation
  • Premature Rupture Of Membranes
  • Cephalic presentation
  • Unfavorable cervix (BISHOP \<7)
  • No contraindication of induction methods

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Parturition

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Florent FUCHS, PUPH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 25, 2020

Study Start

March 1, 2020

Primary Completion

March 30, 2020

Study Completion

August 1, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

FR(1)