Health TrialsbyHealthPanel

The Role of Oxytocin in the Second Stage of Labor

ConditionLabor Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWashington University School of Medicine

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nulliparous pregnant women >/= 37 weeks gestation

Singleton pregnancies

Admission for induction of labor or spontaneous labor

Disqualifiers

Multiple gestations

Multiparous patients

Patients with major fetal anomalies

Not on oxytocin at the time of complete cervical dilation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Discontinue OxytocinOther 1 intervention
Group B: Continue OxytocinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Second stage duration

Time interval from complete cervical dilation to delivery of fetus

Time frame
During admission for delivery

Secondary outcomes

1

Rate of operative delivery

Rate of cesarean section and operative vaginal delivery including forcep or vacuum

Time frame
During admision for delivery
2

Rate of Postpartum hemorrhage

Estimated blood loss \>500 mL for vaginal delivery and \>1000 mL for cesarean delivery

Time frame
During admission for delivery
3

Estimated blood loss

Estimated blood loss at time of delivery (mL)

Time frame
During admission for delivery
4

Rate of chorioamnionitis during the second stage of labor

Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor

Time frame
During admission for delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

University of Michigan

Collaborator

Source ClinicalTrials.gov
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