Management of Prelabor Rupture of the Membranes at Term

Rambam Health Care Campus

Status: Enrolling

Conditions: Chorioamnionitis; Cesarean Section Complications; Fetal Infection; Endometritis

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT04307069

Rambam Health-Care Center

Details and patient eligibility

About

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).

Full 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.

Enrollment: 524 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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524 participants in 2 patient groups

Immediate oxytocin infusion

Experimental group

Description:

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.

Treatment:

Drug: Oxytocin

Expectant management for 24 hours

Experimental group

Description:

Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.

Treatment:

Drug: Oxytocin