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Oxytocin

Pitocin, Syntocinon

Quick Stats
Studies 93
Trials 100
Withdrawn PHASE2 INTERVENTIONAL NCT06550089

High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

Detailed Description

Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon. The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).

Interventions

Name: Oxytocin
Type: DRUG
Description: Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.

Primary Outcomes

Measure: Screen failure rate
TimeFrame: Within 8 hours prior to cesarean delivery
Description: Number of individuals who are eligible for the study but do not consent to participate
Measure: Fidelity rate
TimeFrame: Within 8 hours prior to cesarean delivery
Description: Frequency of fidelity to the trial
Measure: Trial retention rate
TimeFrame: Up to 6 weeks after cesarean delivery
Description: Frequency of participant completion of all study visits
Measure: Acceptability of the intervention
TimeFrame: Up to 6 weeks after cesarean delivery
Description: Frequency of acceptability of the intervention by both participants and their providers

Trial Information

NCT ID

NCT06550089

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

University of Chicago

Last Updated

December 15, 2025