Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage

What Was Tested

This registered phase 4 trial tested Oxytocin.

Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall (hysterotomy).

This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy.

It had two arms (groups): study group (experimental) and control group (active comparator).

Patients will receive buccal misoprostol.

Patients will receive intravenous oxytocin.

The registry classes the interventions as drug.

More on the Plan

General examination and evaluation of the vital signs ofthe patient ( pulse , blood pressure , temperature and respiratory rate) 2.

Obstetrical examination Ultrasonograghic assessment (fetal viability , number of gestation, placental location, amniotic fluid index) Investigations ( complete blood count, Prothrombin time and concentration).

Inclusion criteria: All legally adult pregnant women , above 18 years old ,at term with singleton pregnancies booked for elective caesarean section accepting to participate in the study.

Exclusion criteria: Medical disorders involving the heart,liver,kidney or brain.

Who Took Part

Enrollment: 154 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Booked for elective cesarean section.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: • medical disorders involving the heart,liver,kidney or brain; diabetes mellitus and hypertension; blood disorders (e.g. coagulopathies , thrombocytopenia ).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and care provider.

It started in 2018-11-01 with completion listed for 2021-08-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: mean blood loss (time frame: 1 hour).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 154 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.