Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor

What Was Tested

The trial (phase 2) is built around Oxytocin.

It had three arms (groups): • Group (A) "Study Group 1": (experimental), • Group (B) "Study Group 2": (experimental) and • Group (C) "Control Group": (active comparator).

In the labor room women in Group B (n = 50): * Clamping and cutting the placental cord after delivery of the baby. * Immediate unclamping of the maternal side, allowing the blood to drain freely for a duration of three minutes.

In the labor room women in Group C (n = 50): * Clamping and cutting the placental cord after 2 minutes of delivery of the baby. * Placenta will be delivered spontaneously after appearance of clinical signs of placental separation.

The registry classes the interventions as drug and procedure.

More on the Plan

Study: Study Design: A prospective randomized clinical trial.

Study setting: The study will be conducted in Ain Shams University Maternity Hospital.

All pregnant women in the delivery ward will be submitted to: 1.

Detailed complete history taking with special emphasis to maternal age, Parity, Maternal weight, as well as presence of any disease. 2.

Who Took Part

Enrollment: 150 planned participants were the target.

It was open to women only aged from 18 years up to 35 years.

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

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: medical disorders and hypertensive disorders of pregnancy; known or suspected fetal anomalies; oxytocin induction or augmented cases.

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and care provider.

It started in 2017-09-30 with completion listed for 2018-01-15.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Duration of the third stage of labor (time frame: 5-15 minutes).

It also tracked 3 secondary outcomes, for example Retained placenta, the Need for manual removal of placenta and the drop in hemoglobin in gm/dl.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 150 people.

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.