Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

What Was Tested

This registered not phased trial tested Oxytocin.

After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group.

The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out.

It had two arms (groups): Cook catheter (other) and one (active comparator).

Control.

Test group.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 26 actual participants took part.

It was open to women only aged from 16 years up to 40 years.

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

Examples of who could join: Reassuring fetal status at time of presentation. Bishop Score \<6.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: closed cervix; breech presentation; multiple gestations.

How the Study Was Run

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

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2015-07-01 with completion listed for 2016-07-30.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Time to Delivery (in Hours) (time frame: Up to 60 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 26 people.

Its size is small, so on its own it can only give an early look.

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.