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
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 |
Verified date | September 2020 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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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