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

What Was Tested

The trial (not phased) is built around Oxytocin.

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.

It had two arms (groups): Oxytocin (active comparator) and Oxytocin discontinuation (active comparator).

Continuation of oxytocin per protocol once the patient reaches active labor.

Oxytocin will be stopped once the patient reaches active labor.

The registry classes the interventions as drug.

More on the Plan

Oxytocin is the most common agent used to induce and augment labor.

It is used to induce labor and stimulate or reinforce labor.

The relationship of oxytocin and its receptor is crucial in obtaining adequate uterine activity and thus inducing active labor.

Due to this very balanced relationship, a question exists about the optimal regimen of oxytocin administration for induction of labor and on how long to continue oxytocin once active labor begins.

Who Took Part

Enrollment: 252 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: exclusions include women with multiple gestations, previous cesarean sections, and documented fetal anomalies; women with contraindications to labor or induction will also be excluded.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2009-02 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cesarean Delivery (time frame: 24-72 hours from admission for induction).

It also tracked 1 secondary outcome, for example Perinatal Outcomes.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 252 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.