The Role of Oxytocin in the Second Stage of Labor

NCT ID: NCT04303702

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-09-30

Brief Summary

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

Detailed Description

Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

Conditions

Labor Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Discontinue Oxytocin

Group Type: OTHER

Discontinue Oxytocin

Intervention Type: 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.

Continue Oxytocin

Group Type: ACTIVE_COMPARATOR

Continue Oxytocin

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Nandini Raghuraman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nandini Raghuraman, MD MSCI

Role: CONTACT

nraghuraman@wustl.edu

9186917389

Facility Contacts

Nandini Raghuraman, MD MS

Role: primary

raghuramann@wudosis.wustl.edu

918-691-7389

Other Identifiers

201909112

Identifier Type: -

Identifier Source: org_study_id