Oxytocin Dosing at Planned Cesarean Section and Anemia

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin for anemia.

Patient's with planned cesarean sections will be randomized to receive either standard 20 mU in 1L as a bolus following delivery of the placenta or 20 mu in 1L following delivery of the placenta plus an additional 20 mU in 1L over 8 hours.

It had two arms (groups): Control (placebo comparator) and Treatment (experimental).

Patient will receive standard post-partum Oxytocin (20 mU in 1 L LR) and 1 L LR over 8 hours following delivery.

Patient will receive standard post-partum Oxytocin(20 mU in 1 L LR) an additional 20 mU Oxytocin in 1 L LR over 8 hours following delivery.

The registry classes the interventions as drug.

Who Took Part

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Planned cesarean sections for singletons at or greater than 37 weeks gestational age. Primary or repeat cesarean section will be included.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: multiple fetal pregnancies; hematologic disorders; fetal anomalies.

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.

Neither the anemia 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 and investigator.

It started in 2019-03-01 with completion listed for 2020-03-01.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Blood loss in postpartum period defined by grams/hour (time frame: 3-4 days after delivery).

It also tracked 10 secondary outcomes, for example Change in Hemoglobin, Change in Hematocrit, Length of hospital stay, Need for additional uterotonics, Continuation of breastfeeding and Quantity of narcotic pain medications.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in people with anemia.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Anemia research.