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

The University of Chicago

Status and phase: Withdrawn; Phase 2

Conditions: Cesarean Section Complications; Pregnancy Complications; Postpartum Hemorrhage

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT06550089

IRB24-0398

Details and patient eligibility

About

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.

Full 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).

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria.

• Age 18 or greater
• English or Spanish speaking
• Individuals undergoing a scheduled or unscheduled cesarean delivery

Exclusion criteria

• Patient on therapeutic anticoagulation
• Patient with hypertensive disorder of pregnancy or chronic hypertension
• Patient with preexisting bleeding disorder
• Patient with preexisting cardiac disease
• Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
• Patient undergoing planned cesarean hysterectomy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

High-dose oxytocin

Experimental group

Description:

900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Treatment:

Drug: Oxytocin

Low-dose oxytocin

Active Comparator group

Description:

For unlabored cesarean births: 300 mL/hr (18 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery For laboring cesarean births: 600 mL/hr (36 IU/hr), with a maximum rate of 900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery

Treatment:

Drug: Oxytocin