Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

What Was Tested

This registered phase 4 trial tested Oxytocin.

Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion.

Primary outcome was the incidence of placental retention.

It had two arms (groups): Oxytocin administration after fetal expulsion (experimental) and No additional medication after fetal expulsion (no intervention).

The registry classes the interventions as drug.

More on the Plan

The high incidence of retained placenta is an area of clinical concern.

Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination.

The study is a prospective randomized trial.

It concerns pregnancies between 14 and 28 weeks gestation.

Who Took Part

The registry lists 27 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: 18 years old and older. Medical pregnancy termination between 14 and 28 weeks gestation. Informed consent obtained.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: less than 18 years old; refusal to consent.

How the Study Was Run

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

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

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 2016-10-20 with completion listed for 2017-08-04.

It ran at 1 site in France.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of placental retention (time frame: Up to 30 minutes after fetal expulsion).

It also tracked 5 secondary outcomes, for example Incidence of partial placental retention, Incidence of digital exploration, Incidence of post-partum hemorrhage and Blood loss.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 27 people.

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

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.