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

Mode of Delivery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04565340
• Other study ID #: RECHMPL20_0143
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Mode of Delivery
• Premature Birth
• Premature Rupture of Membranes at Term
• Rupture

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