Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

What Was Tested

This registered not phased trial tested Oxytocin.

Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery.

The investigators do not know the best time after delivery that oxytocin should be given.

It had two arms (groups): Pre-placental group (experimental) and Post-placental group (other).

Oxytocin will be initiated immediately after delivery of the neonatal anterior shoulder (within 15 seconds). This is their "intervention" group. Saline placebo will be initiated post placenta delivery (within 15 seconds).

Saline placebo will be initiated post fetal shoulder delivery (within 15 seconds). Oxytocin will be initiated immediately after placenta delivery (within 15 seconds).

The registry classes the interventions as other.

More on the Plan

The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping.

Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin.

Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels.

There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference.

Who Took Part

The registry lists 104 actual participants 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: All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable. Women aged 18 years or older. Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: multifetal gestation; placental abruption or antepartum hemorrhage; maternal bleeding disorder.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2020-12-10 with completion listed for 2021-04-02.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change in Hemoglobin (time frame: Up to 24 hours).

It also tracked 2 secondary outcomes, for example Cumulative Maternal Adverse Outcomes and Cumulative Neonatal Adverse Outcomes.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 104 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.