Intramuscular Oxytocics: A Randomised Control Trial

What Was Tested

This registered phase 3 trial tested Oxytocin and Carbetocin.

It had three arms (groups): Carbetocin (experimental), Syntocinon (active comparator) and Syntometrine (active comparator).

The registry classes the interventions as drug.

More on the Plan

The most common cause of PPH is an inadequately contracted womb after childbirth.

In the UK, the two medicines most commonly used for this purpose are Syntocinon and Syntometrine.

Investigators estimate that 40,000-70,000 women per year are experiencing distressing nausea and vomiting in the emotionally important first few hours following childbirth.

These women are also receiving a medicine with the potential to cause dangerous high blood pressure.

Who Took Part

5798 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: ≥18 years of age at time of delivery. Vaginal birth (spontaneous and instrumental). \>24 weeks gestation.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: maternal coagulation disorder; patients who would decline blood products if required; known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled).

How the Study Was Run

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

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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, care provider, investigator and outcomes assessor.

It started in 2015-02 with completion listed for 2018-08-31.

It ran at 5 sites in United Kingdom (5).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Requirement for additional uterotonic drugs within 24 hours of birth.

It also tracked 12 secondary outcomes, for example Estimated volume of blood loss at delivery, Transfusion of blood products (type and number of units given), Manual removal of placenta in theatre, Requirement for surgical intervention to manage PPH, Maternal hypertension and Maternal hypotension.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin and Carbetocin in 5798 people.

With 5798 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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