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

Summary

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


Eligibility

Sex: FEMALE

Inclusion Criteria3

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

Exclusion Criteria6

  • 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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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.


Locations(1)

Barnes Jewish Hospital

St Louis, Missouri, United States

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NCT04303702


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