The Role of Oxytocin in the Second Stage of Labor

Not Applicable

Recruiting

• Conditions: Labor Complication
• Interventions: Other: Discontinue Oxytocin; Drug: Continue Oxytocin

• Registration Number: NCT04303702
• Lead Sponsor: Washington University School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-11
• Study Start: 2022-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Discontinue Oxytocin	Discontinue Oxytocin	-
Continue Oxytocin	Continue Oxytocin	-

Primary Outcome Measures

Name	Time	Method
Second stage duration	During admission for delivery	Time interval from complete cervical dilation to delivery of fetus

Secondary Outcome Measures

Name	Time	Method
Rate of Postpartum hemorrhage	During admission for delivery	Estimated blood loss \>500 mL for vaginal delivery and \>1000 mL for cesarean delivery
Rate of composite neonatal morbidity	During admission for delivery	1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.
Rate of chorioamnionitis during the second stage of labor	During admission for delivery	Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Rate of operative delivery	During admision for delivery	Rate of cesarean section and operative vaginal delivery including forcep or vacuum
Rate of severe perineal laceration	During admission for delivery	3rd or 4th degree perineal laceration
Estimated blood loss	During admission for delivery	Estimated blood loss at time of delivery (mL)
Rate of endometritis	During admission for delivery	Postpartum endometritis as diagnosed by primary provider

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States