Clinical trial

Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term

Name

Rambam Health-Care Center

Description

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).

Trial arms

Trial start

2020-05-01

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Treatment

Oxytocin

The drug wil be adminisrate for augmentation of labor at admission.

Arms:

Expectant management for 24 hours, Immediate oxytocin infusion

Other names:

pitocin

Size

524

Primary endpoint

Maternal infectious morbidity

Up to 48 hours postpartum

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 524, 'type': 'ESTIMATED'}}

Updated at

2024-04-12

1 organization

1 product

4 indications

Organization

Rambam Health Care Campus

Product

Indication

Indication

Indication

Indication

Cesarean Section Complications