Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

What Was Tested

The trial (not phased) is built around Oxytocin.

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

The registry classes the interventions as drug.

More on the Plan

The design of this study is a randomized, controlled study with two arms.

Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice.

Group B, intravaginal placement of misoprostol, will serve as the experimental group.

Who Took Part

The registry lists 50 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participant or surrogate is capable of giving informed consent. Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy. Participant is undergoing an indicated induction of labor. Participant is found to have cervical Bishop score ≤5 on initial cervical exam. Participant has no medical or obstetrical contraindications to induction of labor.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods; manufacturer's contraindications to misoprostol or oxytocin.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

The Oxytocin group and the comparison group ran side by side rather than switching.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2009-09 with completion listed for 2010-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of Induction To Delivery (time frame: 24 hrs).

It also tracked 1 secondary outcome, for example Delivery Route.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 50 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.