Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)

What Was Tested

This registered early phase 1 trial tested Oxytocin.

It had two arms (groups): Placebo (placebo comparator) and Treatment (experimental).

Normal Saline (standard of care).

Normal saline + oxytocin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 66 actual participants took part.

It was open to women only aged from 13 years up to 45 years.

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

Examples of who could join: Vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age;.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: abnormal placentation (previa, accreta, etc); antenatal hemorrhage; contraindication to oxytocin.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2015-02 with completion listed for 2019-07-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Evaluation of Postpartum hematocrit (time frame: 24 hours postpartum).

It also tracked 3 secondary outcomes, for example Primary postpartum hemorrhage, Estimated blood loss at delivery and Postpartum blood loss.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin in 66 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.