Clinical trial

Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor in Multiparous Pregnant Women

Name

RMB-0517-23

Description

This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion.

Trial arms

Trial start

2024-04-01

Estimated PCD

2026-04-01

Trial end

2027-04-01

Status

Not yet recruiting

Treatment

Pitocin Injectable Product

The primary dose of oxytocin is 1.0 mU/min, with an incremental increase by 2.5 mU/min every 30 minutes, until 20.0 mU/min, tittered to a target of 3-5 contractions in a 10-minute period, or active labor (dilatation \> 6 cm).

Arms:

continuous oxytocin infusion, intermittent oxytocin infusion

Other names:

Synthetic Oxytocin

Size

166

Primary endpoint

The rate of women delivering within 24 hours.

During admission for delivery (assessed up to 5 days since admission to delivery room)

Eligibility criteria

Inclusion Criteria: * multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor. * Women at gestational age of 370/7 or more. * Vertex presentation. Exclusion Criteria: * Age 18 and under. * High order gestation. * Women with contraindication for vaginal delivery. * Previous cesarean delivery. * Active labor. * Documented fetal anomalies.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 166, 'type': 'ESTIMATED'}}

Updated at

2024-04-18

1 organization

1 product

1 indication

Organization

Rambam Health Care Campus

Product

Pitocin

Indication

Pregnancy Related