Management of the Third Stage of Labor

What Was Tested

This registered phase 3 trial tested Oxytocin.

It had three arms (groups): Intramuscular treatment:IV (experimental), Combined treatment:IV+IM (experimental) and The control group (active comparator).

The registry classes the interventions as drug.

More on the Plan

The third stage of labor refers to the period following the completed delivery of the newborn until the completed delivery of the placenta.

The length of the third stage and its complications are affected by the uterine contractility and the duration of placental separation.

The normal duration of third stage in nulliparous as well as in multiparous women is less than 30 minutes.

Active management of the third stage of labor involves prophylactic uterotonic treatment, early cord clamping and controlled cord traction to deliver the placenta.

Who Took Part

The registry lists 500 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: 34-41 weeks of gestation. Maternal age between 18 and 45.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm); coagulation defects; VAS score\>3 (pain score).

How the Study Was Run

It was run as a randomized, parallel-group and open-label 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.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2015-09 with completion listed for 2017-01.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hemoglobin concentration during labor (time frame: first and second day after delivery).

It also tracked 1 secondary outcome, for example Blood count (CBC) on the first and second day after delivery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 500 people.

With 500 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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