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Induction of Labor With Oxytocin: When Should Oxytocin be Held?

NCT00957593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2019-04-23

Study results available
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Summary

The investigators propose to perform a prospective randomized control trial to compare the rate of cesarean delivery in women where Oxytocin (OT) is discontinued once active labor begins (5 cm dilation) when compared with women where OT is continued at a maintenance level per the usual protocol.

One study group will follow an oxytocin protocol which is incremental until 5 cm dilation and then maintained at the same level throughout labor. The second arm will follow an oxytocin protocol also incremental, but then discontinued once the cervix is 5 cm. The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart rate abnormalities, and frequency of uterine hyperstimulation, maternal and neonatal outcomes.

As mentioned in the study proposal, the proposed experimental arm is currently not performed as part of the oxytocin guidelines at the investigators' institution. One study from Israel suggests no difference in pregnancy outcomes with the proposed use of oxytocin. Although some providers stop the oxytocin in active labor for their patients, this is not a commonly performed procedure at the investigators' institution. The investigators are not aware of other institutions employing the above practice.

Conditions

  • Labor Induction
  • Cesarean Delivery

Interventions

DRUG

Oxytocin

Continuation of oxytocin once in active labor

DRUG

Oxytocin discontinuation

Oxytocin will be stopped once in active labor

Sponsors & Collaborators

  • Lehigh Valley Hospital

    lead OTHER

Principal Investigators

  • Joanne N Quinones, MD MSCE · Lehigh Valley Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957593 on ClinicalTrials.gov