Outpatient Labor Induction With the Transcervical Foley Balloon

What Was Tested

This registered not phased trial tested Oxytocin.

This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter.

The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ.

The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge.

It had two arms (groups): inpatient Foley balloon induction (active comparator) and outpatient Foley balloon induction (experimental).

The registry classes the interventions as device and drug.

More on the Plan

This is a randomized controlled trial.

Patients who are candidates for labor induction and meet inclusion criteria will be identified in the obstetrics clinic when they are being scheduled for induction of labor, or at a later clinic date.

If they agree to participate, patients will be randomized and enrolled in the study at that time.

Those who consent will be randomized into Group A (Experimental Group) and Group B (Control Group).

Who Took Part

Enrollment: 64 planned participants were the target.

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: Viable Intrauterine Pregnancy. Greater than or equal to 37 weeks gestation on date of induction. Medically indicated induction of labor. AFI greater than or equal to 5. Cervical Dilation 2cm or less.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: placenta previa/low lying placenta; placenta accreta/increta/percreta; undiagnosed vaginal bleeding.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2014-03 with completion listed for 2018-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Duration of inpatient hospitalization (hours) (time frame: time from hospital admission to time to discharge, on average 96 hours).

It also tracked 8 secondary outcomes, for example Duration of labor induction (hours), Cesarean section rate (percentage), Duration of oxytocin use during labor induction (hours), Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage), Rate of patients developing chorioamnionitis during labor induction (percentage) and Rate of patients developing uterine tachysystole during labor induction (percentage).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 64 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.