Recruiting

Oxytocin

Sponsor:

Washington University School of Medicine

Code:

NCT04303702

Conditions

Labor Complication

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Continue Oxytocin

Discontinue Oxytocin

Study Details

Brief summary:

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Conditions

Labor Complication

Study ID

NCT04303702

Start date

Jul 1, 2022

Status verified date

Dec, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Nulliparous pregnant women >/= 37 weeks gestation
  • Singleton pregnancies
  • Admission for induction of labor or spontaneous labor

Exclusion Criteria:

  • Multiple gestations
  • Multiparous patients
  • Patients with major fetal anomalies
  • Not on oxytocin at the time of complete cervical dilation
  • Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
  • Maternal medical condition that prohibits prolonged second stage

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Discontinue Oxytocin

active comparator: Continue Oxytocin

Interventions

Continue Oxytocin

The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion.

Discontinue Oxytocin

Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.

Primary outcome measure

  • Second stage duration [ Time Frame: During admission for delivery ]

Central Contacts and Locations

Central contacts

Nandini Raghuraman, MD MSCI

9186917389nraghuraman@wustl.edu

Locations

Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Nandini Raghuraman, MD MS

918-691-7389raghuramann@wudosis.wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-01-05.