Oxytocin in Multiparous Women

NCT06372522 | Not Yet Recruiting

• 1 other identifier: RMB-0517-23
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• The rate of women delivering within 24 hours.

  number of women (among those who received continues Oxytocin) who manage to deliver within 24 hours from the beginning of the induction.

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

Secondary Outcomes (10)

• Length of latent and active phases of labor.

  During admission for delivery

• The rate of instrumental and caesarean deliveries.

  During admission for delivery

• chorioamnionitis

  During admission for delivery

• obstetric anal sphincter injuries (OASIS)

  During admission for delivery

• hyponatremia

  During admission for delivery

Study Arms (2)

continuous oxytocin infusion

EXPERIMENTAL

continuous oxytocin infusion - women will continue to receive a continuous oxytocin infusion from start of labor augmentation until delivery.

Drug: Pitocin Injectable Product

intermittent oxytocin infusion

ACTIVE COMPARATOR

intermittent oxytocin infusion - oxytocin transfusion will be discontinued after 8 hours if the woman does not go into active labor, or does not deliver in that period of time. The second course of oxytocin will be renewed after 6 hours if the woman hasn't progressed into labor or hasn't given birth yet.

Drug: Pitocin Injectable Product

Interventions

Pitocin Injectable Product DRUG

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).

Also known as: Synthetic Oxytocin

continuous oxytocin infusion; intermittent oxytocin infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age 18 and under.
• High order gestation.
• Women with contraindication for vaginal delivery.
• Previous cesarean delivery.
• Active labor.
• Documented fetal anomalies.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in OB-GYN, Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 18, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share