Prophylactic Use of Intraumbilical Vein Oxytocin Injection in The Management of Third Stage of Labor

What Was Tested

The trial (phase 1) is built around Oxytocin.

The third stage is the interval between delivery of the infant and delivery of the placenta.

This stage averages 10 minutes and is considered prolonged if it lasts longer than 30 minutes, placental separation occurs as a result of continued uterine contractions, continued contractions control blood loss by compression of spiral arteries and also result in migration of the placenta into the lower uterine segment and then through the cervix.

It had two arms (groups): oxytocin group (active comparator) and control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The duration of the third stage of labor by stopwatch. 2.

Hemoglobin (Hb) difference before and 12 h after delivery. 3.

The need for manual delivery of the placenta.

Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery. 4.

Who Took Part

Enrollment: 1 planned participants were the target.

It was open to women only aged from 14 years up to 50 years.

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

Examples of who could join: 36 to 42 weeks gestational age. Single alive fetus with cephalic presentation. Parity 1 to 3. Normal vaginal delivery.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: placenta previa; placental abruption ; prolonged labor ( \> 20 h ).

How the Study Was Run

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: care provider.

It started in 2015-01 with completion listed for 2016-02.

It ran at 1 site in Egypt.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Duration of the third stage of labor (time frame: more than 30 minutes, we will do manual separation of placenta).

It also tracked 1 secondary outcome, for example Hb difference before and 12 h after delivery.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 1 people.

Its size is small, so on its own it can only give an early look.

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.