Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

What Was Tested

This registered early phase 1 trial tested Oxytocin.

To compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome.

It had two arms (groups): prostaglandins (active comparator) and intracervical balloon catheter with pitocin (active comparator).

Vaginal prostaglandins insertion (PGE2) for cervical ripening and induction.

Insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor.

The registry classes the interventions as device and drug.

More on the Plan

Intra uterine growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in uterus.

The excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week.

Severe growth restriction is defined as estimated weight below the 3rd percentile.

There are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (PGE2) for cervical ripening, intracervical balloon catheter or planned cesarean.

Who Took Part

Enrollment: 280 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally. Gestational age between 36 and 42 weeks. No known fetal anomalies.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: fetal estimated weight below the 3rd percentile; known fetal anomalies; contraindications for vaginal delivery: breech presentation, abnormal doppler flow velocimetry of fetal ductus venosus.

How the Study Was Run

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

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2018-09 with completion listed for 2020-07.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): mode of delivery (time frame: immediate).

It also tracked 1 secondary outcome, for example composite neonatal outcome.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 280 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.