A Randomized, Control Trial for Preinduction Cervical Ripening

What Was Tested

The trial (phase 2) is built around Oxytocin.

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol).

Secondary goals are to measure and compare the time intervals to delivery between the two methods.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 540 planned participants were the target.

It was open to women only.

Examples of who could join: Women that are hospitalized for induction of labor that have a Bishop's score \<5. 24 weeks gestational age.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: prior uterine surgery; placenta previa or abruption; clinically suspected or diagnosed intra amniotic infection.

How the Study Was Run

It was run as a randomized, single-group and single-blind study.

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.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-01 with completion listed for 2007-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Vaginal Delivery rates.

It also tracked 1 secondary outcome, for example Time interval to delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 540 people.

With 540 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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