The Role of Oxytocin in the Second Stage of Labor

Labor Complication Clinical Trial

— ROSSoL  

Official title:

Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303702
• Other study ID #: 201909112
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Nandini Raghuraman, MD MSCI
• Phone: 9186917389
• Email: nraghuraman[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Complication
• Obstetric Labor Complications

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Second stage duration	Time interval from complete cervical dilation to delivery of fetus	During admission for delivery
Secondary	Rate of operative delivery	Rate of cesarean section and operative vaginal delivery including forcep or vacuum	During admision for delivery
Secondary	Rate of Postpartum hemorrhage	Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery	During admission for delivery
Secondary	Estimated blood loss	Estimated blood loss at time of delivery (mL)	During admission for delivery
Secondary	Rate of chorioamnionitis during the second stage of labor	Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor	During admission for delivery
Secondary	Rate of endometritis	Postpartum endometritis as diagnosed by primary provider	During admission for delivery
Secondary	Rate of severe perineal laceration	3rd or 4th degree perineal laceration	During admission for delivery
Secondary	Rate of composite neonatal morbidity	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.	During admission for delivery