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Management of Prelabor Rupture of the Membranes at Term

Management of Prelabor Rupture of the Membranes at Term

Recruiting
18-45 years
Female
Phase N/A

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Overview

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 labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

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 expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.

In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.

Eligibility

Inclusion Criteria:

  1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
  2. Women at gestational age 370/7 or more.
  3. Vertex presentation.

Exclusion Criteria:

  1. Age 18 and under.
  2. High order gestation.
  3. Women with contraindication for a vaginal delivery.
  4. Active labor.
  5. Documented fetal anomalies.
  6. Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
  7. Non reassuring fetal heart rate tracing.
  8. Positive group B streptococcus status.

Study details
    Fetal Infection
    Chorioamnionitis
    Endometritis
    Cesarean Section Complications

NCT04307069

Rambam Health Care Campus

21 October 2025

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