The Role of Oxytocin in the Second Stage of Labor

NCT04303702 | Recruiting DMC

• 1 other identifier: 201909112
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor Complication

Outcome Measures

Primary Outcomes (1)

• Second stage duration

  Time interval from complete cervical dilation to delivery of fetus

  During admission for delivery

Secondary Outcomes (7)

• Rate of operative delivery

  During admision for delivery

• Rate of Postpartum hemorrhage

  During admission for delivery

• Estimated blood loss

  During admission for delivery

• Rate of chorioamnionitis during the second stage of labor

  During admission for delivery

• Rate of endometritis

  During admission for delivery

Study Arms (2)

Discontinue Oxytocin

OTHER

Other: Discontinue Oxytocin

Continue Oxytocin

ACTIVE COMPARATOR

Drug: Continue Oxytocin

Interventions

Continue Oxytocin DRUG

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.

Continue Oxytocin

Discontinue Oxytocin OTHER

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.

Discontinue Oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Michigan: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Nandini Raghuraman, MD MSCI

CONTACT

9186917389; nraghuraman@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 11, 2020
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)