Oxytocin Administration During Cesarean Section

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.

Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: Primigravida or multigravida. Term (37 - 42 weeks),. Booked for elective caesarean section. Accepting to participate in the study.

The full record lists 5 inclusion and 12 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

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

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.

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2016-10 with completion listed for 2017-08.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: rate of blood loss (time frame: 4 hours).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 200 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.