Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion

What Was Tested

The trial (phase 4) is built around Oxytocin.

This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions.

Primary outcome of the study is complete abortion rate within two hours of fetal delivery.

It had two arms (groups): Oxytocin (active comparator) and Observation (no intervention).

The registry classes the interventions as drug.

Who Took Part

The registry lists 160 actual participants took part.

It was open to women only aged from 17 years up to 45 years.

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

Examples of who could join: Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: if fetus and placenta expelled together; obstetrical haemorrhage needs intervention; known prostaglandin allergy.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2015-06-08 with completion listed for 2016-05-31.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Complete abortion rate (time frame: within 5 minute after placenta delivered).

It also tracked 4 secondary outcomes, for example Blood loss estimated by gravimetric method, Transfusion rate, Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion and Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 160 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.