Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour

What Was Tested

The trial (not phased) is built around Oxytocin.

This complication is amongst the most challenging that a clinician will face in the obstetric patient.

The registry classes the interventions as drug.

More on the Plan

This complication is amongst the most challenging that a clinician will face in Obstetrics.

The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine.

The effect of oxytocin is limited by the number and status of the oxytocin receptors.

Therefore, a different uterotonic agent, involving a different mechanism of action should be used instead.

Who Took Part

The registry lists 47 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: Cesarean section secondary to failure to progress in labour. First stage of labour. Received oxytocin for at least 4 hours.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: require general anesthesia; cardiac disease; predisposition to uterine atony and postpartum hemorrhage.

How the Study Was Run

The set-up was randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

It started in 2005-06 with completion listed for 2007-01.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Blood loss (time frame: During surgery).

It also tracked 2 secondary outcomes, for example Side Effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 47 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.