The Role of Oxytocin in the Second Stage of Labor

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04303702
Status
Recruiting
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Conditions

  • Labor Complication

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Continue Oxytocin — 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.
  • Discontinue Oxytocin — 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.

Study Details

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

Key Dates

Start date
Jul 1, 2022
Status verified
Dec 2025
Primary completion
Jun 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Discontinue Oxytocin
  • Active Comparator: Continue Oxytocin

Primary Outcome Measure

Second stage duration [ Time Frame: During admission for delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barnes Jewish HospitalSt LouisMissouri63110
Nandini Raghuraman, MD MS
[email protected]
918-691-7389

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By research site
Barnes Jewish Hospital· St Louis, MO

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