Ideal Time of Oxytocin Infusion During Cesarean Section

What Was Tested

The trial (phase 4) is built around Oxytocin for post-surgical inflammation and surgery recovery.

This study will evaluate if the timing of oxytocin administration in cesarean deliveries will affect the amount of maternal blood loss.

Half of participants will receive oxytocin after delivery of the fetal anterior shoulder and the other half will receive oxytocin after delivery of the placenta.

The researchers hypothesize that administering oxytocin after delivery of the shoulder, will result in less overall maternal blood loss.

It had two arms (groups): Control (Group A) (placebo comparator) and Intervention (Group B) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Oxytocin is a routinely administered medication for both vaginal and cesarean deliveries in the third stage of labor, as part of standard of care in the United States.

Currently evidence is lacking to direct timing of oxytocin administration in cesarean deliveries.

This study will evaluate both estimated and quantitative blood loss for both groups of patients.

It will also compare the change from pre-operative to post-operative hemoglobin levels.

Who Took Part

The registry lists 68 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: Women who read and speak the English and/or Spanish language. Women age 18 or older.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: women who deliver vaginally; gestation under 37 weeks and 0 days; women with coagulopathies.

How the Study Was Run

Design: randomized, parallel-group and triple-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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2017-09-13 with completion listed for 2020-02-24.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total blood loss (time frame: At the completion of the surgery when patient is transferred to recovery from the operating room).

It also tracked 3 secondary outcomes, for example Incidence of postpartum hemorrhage, Need for transfusion and Change in pre-operative to post-operative hemoglobin levels.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 68 people with post-surgical inflammation and surgery recovery.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Post-surgical inflammation and surgery recovery research.