Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

What Was Tested

The trial (phase 2) is built around Oxytocin.

The purpose of this study is to examine the feasibility of using intracervical balloon catheters for cervical ripening as part of labour induction in healthy, GBS-negative women with prelabour rupture of membranes at term.

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

Induction of Labour with Oxytocin Alone.

Insertion of an Intracervical Balloon Catheter plus administration of oxytocin for labour induction.

The registry classes the interventions as drug and procedure.

More on the Plan

This is a randomized controlled trial comparing two methods of induction of labour for pregnant, GBS-negative women presenting with prelabour rupture of membranes at term.

The intervention consists of the insertion of a double-balloon intracervical catheter at the time of induction, followed immediately by oxytocin infusion.

The control consists of standard therapy: oxytocin induction.

Their primary outcome is feasibility, and their secondary outcomes are length of first and second stages of labour, rate of vaginal delivery, intrapartum fever, chorioamnionitis, NICU admission, suspected or proven neonatal sepsis, or serious neonatal complication.

Who Took Part

Enrollment: 5 actual participants took part.

It was open to women only.

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

Examples of who could join: 37.0 and 41.0 gestational age. Confirmed Rupture of Membranes. Group B Streptococcus Negative. Absence of contractions for at least 60 minutes following rupture. Absence of contractions at time of enrolment.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: contraindication to vaginal delivery; previous uterine surgery, including caesarean section; previous cerclage, cone biopsy, leep, or cervical surgery.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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: outcomes assessor.

It started in 2010-04 with completion listed for 2011-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Feasibility (time frame: 48 hours).

It also tracked 5 secondary outcomes, for example Intrapartum Fever, Duration of Labour, NICU Admission, Chorioamnionitis and Patient Satisfaction.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 5 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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