Status:
RECRUITING
Management of Prelabor Rupture of the Membranes at Term
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Fetal Infection
Chorioamnionitis
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment l...
Detailed Description
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions. PROM at term can be managed actively by induction of labor or exp...
Eligibility Criteria
Inclusion
- Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
- Women at gestational age 370/7 or more.
- Vertex presentation.
Exclusion
- Age 18 and under.
- High order gestation.
- Women with contraindication for a vaginal delivery.
- Active labor.
- Documented fetal anomalies.
- Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis).
- Non reassuring fetal heart rate tracing.
- Positive group B streptococcus status.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT04307069
Start Date
May 1 2020
End Date
May 1 2024
Last Update
April 12 2024
Active Locations (1)
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1
Rambam
Ramat Yishai, Israel, 3009500