Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?

What Was Tested

This registered not phased trial tested Oxytocin.

Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section.

Both of these methods are commonly used.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.

In one group, women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born.

The registry classes the interventions as drug.

More on the Plan

Women who participate will be randomized (like a toss of a coin) to one of two groups.

Neither the woman nor the anesthesiologist nor the obstetrician will know which group they are in.

In one group, the women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born.

In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.

Who Took Part

Enrollment: 150 actual participants took part.

It was open to women only aged from 19 years with no upper age limit.

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

Examples of who could join: Aged 19 years or over. Having a cesarean section. Have one or more of the following. A larger than average uterus, because of. A large baby.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: active bleeding and their blood pressure or pulse rate are not normal; blood does not clot normally; aged less than 19 years.

How the Study Was Run

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

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2005-11 with completion listed for 2006-10.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Need for additional oxytocics in women at high risk of hemorrhage (time frame: within the first hour after delivery).

It also tracked 1 secondary outcome, for example Secondary outcomes include uterine tone and side effects.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 150 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.