Management of Prelabor Rupture of the Membranes at Term

Not Applicable

Recruiting

• Conditions: Endometritis; Cesarean Section Complications; Fetal Infection; Chorioamnionitis
• Interventions: Drug: Oxytocin

• Registration Number: NCT04307069
• Lead Sponsor: Rambam Health Care Campus

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

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 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.

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-13
• Study Start: 2020-05-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 524

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate oxytocin infusion	Oxytocin	Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
Expectant management for 24 hours	Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Maternal infectious morbidity	Up to 48 hours postpartum	Maternal chorioamnionitis and/ or endometritis

Secondary Outcome Measures

Name	Time	Method
Adverse maternal outcome	Up to 48 hours postpartum	infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).
Length of latent and active phases of labor.	During Labor	According to vaginal examinations during labor
Adverse neonatal outcome	Up to 48 hours postpartum	stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score \< 7, umbilical artery pH \< 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.

Trial Locations

Locations (1)

Rambam; 🇮🇱 Ramat Yishai, Israel