RecruitingNot ApplicableNCT04303702

The Role of Oxytocin in the Second Stage of Labor

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

Sponsor

Washington University School of Medicine

Enrollment

400 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Labor Complication

Summary

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

Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is examining the role of oxytocin — a hormone routinely used to strengthen or continue labor contractions — during the second stage of labor (the pushing phase). Specifically, it investigates whether continuing or stopping oxytocin when a woman is fully dilated and ready to push affects delivery outcomes. Some clinicians believe continuing the medication helps labor progress, while others worry it may increase the risk of uterine hyperstimulation or other complications during pushing. Participants will be randomly assigned to either continue or discontinue oxytocin infusion at the start of the second stage of labor. Researchers will track outcomes such as time to delivery, mode of delivery, and any complications for mother or baby. You may be eligible if you: - Are pregnant for the first time (nulliparous) - Are at least 37 weeks pregnant - Are carrying a single baby - Were admitted for induction of labor or spontaneous labor - Are on oxytocin at the time of full cervical dilation You may NOT be eligible if you: - Are carrying multiple babies (twins, triplets, etc.) - Have given birth before (multiparous) - Have major fetal anomalies - Are not on oxytocin at the time of full dilation - Already have the baby's head visible at the perineum at the time of full dilation - Have a medical condition that prohibits an extended second stage of labor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGContinue 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.

OTHERDiscontinue 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.