Clinical trial NCT06550089: High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
Official title: A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Pregnancy Complications
Cesarean Section Complications
Keywords: oxytocin
cesarean delivery
postpartum hemorrhage
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2024-08-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Screen failure rate
timeFrame: Within 8 hours prior to cesarean delivery
measure: Fidelity rate
timeFrame: Within 8 hours prior to cesarean delivery
measure: Trial retention rate
timeFrame: Up to 6 weeks after cesarean delivery
measure: Acceptability of the intervention
timeFrame: Up to 6 weeks after cesarean delivery
Secondary outcomes:
measure: Maternal flushing
timeFrame: During and up to 6 hours after cesarean delivery
measure: Maternal hypotension
timeFrame: During and up to 6 hours after cesarean delivery
measure: Maternal nausea/vomiting
timeFrame: During and up to 6 hours after cesarean delivery
measure: Myocardial ischemia
timeFrame: During and up to 24 hours after cesarean delivery
measure: Cardiac arrhythmia
timeFrame: During and up to 24 hours after cesarean delivery
measure: Quantitative blood loss greater than 1 liter
timeFrame: Within 24 hours after cesarean delivery
measure: Need for blood product transfusion, inclusive of type and number of blood products transfused
timeFrame: Within 4 days after cesarean delivery
measure: Frequency of increase in oxytocin rate in low-dose arm
timeFrame: During and up to 6 hours after cesarean delivery
measure: Additional use of uterotonics and/or tranexamic acid
timeFrame: During and up to 24 hours after cesarean delivery
measure: Placement of intrauterine balloon tamponade or suction device
timeFrame: During and up to 24 hours after cesarean delivery
measure: Surgical management of hemorrhage, inclusive of hysterectomy
timeFrame: During and up to 24 hours after cesarean delivery
measure: Intensive care unit admission
timeFrame: During and up to 24 hours after cesarean delivery
measure: Maternal death
timeFrame: During and up to 6 weeks after cesarean delivery
measure: Readmission to the hospital or reoperation
timeFrame: Up to 6 weeks after cesarean delivery
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Ashish Premkumar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Anna Palatnik, MD
role: PRINCIPAL_INVESTIGATOR
References: