Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Titrated Oral Misoprostol Solution.

Intravenous Oxytocin.

The registry classes the interventions as drug.

More on the Plan

Numerous labor course necessitate augmentation when uterine contractions are inadequate.

When the cervix is favorable, labor augmentation attempts are more likely to be successful.

Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination.

Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.

Who Took Part

Enrollment: 143 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Pregnancy between 36 and 42 weeks of gestation. A reassuring fetal heart rate pattern. Bishop score greater than 6. Inadequate uterine contraction (less than or equal to 2 per 10 minutes).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: nonreassuring fetal heart rate pattern; parity more than five; uterine scar.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2008-02 with completion listed for 2008-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the percentage of women delivering infants vaginally within 12 hours of augmentation (time frame: post vaginal delivery).

It also tracked 1 secondary outcome, for example uterine hyperstimulation rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 143 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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