Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor

What Was Tested

This registered phase 3 trial tested Oxytocin.

During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life.

Retained placenta is an another complication of third stage of labor.

It had 1 arm (groups): Saline group (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 412 actual participants took part.

It was open to women only aged from 15 years up to 35 years.

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

Examples of who could join: Gestational age between 37 and 42 weeks. Parity between one and five. Maternal age \< 35 years.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: blood pressure ≥ 140/90mmhg; placenta previa; placental abruption.

How the Study Was Run

The set-up was randomized and quadruple-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.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2009-12 with completion listed for 2010-03.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): the amount of blood loss in third and fourth stages of labor (time frame: The end of the delivery to 2 hours after birth).

It also tracked 1 secondary outcome, for example duration of the third stage.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 412 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.