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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04565340
Other study ID # RECHMPL20_0143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date August 1, 2020

Study information

Verified date September 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date August 1, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mode of delivery, maternal and neonatal outcomes/complications
Mode of delivery, maternal and neonatal outcomes/complications

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary mode of delivery (vaginal delivery or cesarean) mode of delivery (vaginal delivery or cesarean) 1 day
Secondary maternal and fetal outcomes 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
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