Foley Labor Induction Trial at Term and in PROM

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.

Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place.

It had four arms (groups): Control (no intervention), Oxytocin (experimental), PROMS Foley and oxytocin (experimental) and PROMS no Foley bulb (no intervention).

No oxytocin while the Foley bulb is in place.

Use of oxytocin while the Foley bulb is in place.

Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.

The registry classes the interventions as drug.

Who Took Part

312 actual participants took part.

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

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

Examples of who could join: Women at \> 24 weeks gestation. A non-anomalous, singleton fetus in a vertex presentation.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: history of prior uterine surgery such as cesarean section or myomectomy; unexplained vaginal bleeding; latex allergy.

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.

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.

It started in 2014-11 with completion listed for 2016-04-18.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): induction time to delivery (time frame: Time from induction to delivery, average 12-28 hours).

It also tracked 5 secondary outcomes, for example Mode of delivery, estimated blood loss, uterine atony, chorioamnionitis and neonatal birthweight.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 312 people.

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.