CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 252 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00957593
NCT00957593N/ACompleted

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

Lehigh Valley Hospital·interventional·Posted Aug 12, 2009·Updated Apr 23, 2019

In Brief

A clinical study evaluating Oxytocin and Oxytocin discontinuation for Labor Induction and Cesarean Delivery. Completed, enrolled 252 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2009
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago

Interventions

Oxytocindrug

Continuation of oxytocin once in active labor

Oxytocin discontinuationdrug

Oxytocin will be stopped once in active labor