Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness.

It had three arms (groups): 1 (no intervention), 2 (active comparator) and 3 (active comparator).

No specific oxytocic to assist in placental delivery.

Intramuscular oxytocin injection.

Oral misoprostol to assist in placental delivery.

The registry classes the interventions as drug.

More on the Plan

Methods: All women who are admitted to King Edward Memorial Hospital for Women for pregnancy interruption for severe fetal anomaly or maternal pregnancy complications between 14 and 24 weeks gestation will be invited to participate in the study.

Once consent has been obtained, the women will be randomised to three placental management strategy groups: Group 1: Standard management protocol; Group 2: Oxytocin protocol; Group 3: Oral misoprostol protocol.

Group 1: Women allocated to the standard management protocol will receive no routine oxytocic following the delivery of the fetus.

If spontaneous placental expulsion has not occurred within 60 minutes of delivery, or if heavy vaginal bleeding ensues within that time period, manual removal of the placenta will be performed in the operating room under general or regional anaesthesia.

Who Took Part

The registry lists 251 actual participants took part.

It was open to women only aged from 16 years up to 50 years.

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

Examples of who could join: Abortion at 14-24 weeks gestation. Medical termination with vaginal misoprostol.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: surgical termination; gestation less than 14 weeks or greater than 24 weeks.

How the Study Was Run

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

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.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2005-02 with completion listed for 2007-12.

It ran at 1 site in Australia.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Placental Retention Rate (time frame: 3 years).

It also tracked 2 secondary outcomes, for example Post-Delivery Blood Loss and Endometrial Appearances Postpartum.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 251 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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