A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)
Overview
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- University of Chicago
- Enrollment
- 100
- Primary Endpoint
- Fidelity rate
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
High-dose oxytocin
900 mL/hr (54 units/hr) intravenously for the duration of the cesarean delivery
Intervention: Oxytocin (Drug)
Low-dose oxytocin
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
Intervention: Oxytocin (Drug)
Outcomes
Primary Outcomes
Fidelity rate
Time Frame: Within 8 hours prior to cesarean delivery
Frequency of fidelity to the trial
Acceptability of the intervention
Time Frame: Up to 6 weeks after cesarean delivery
Frequency of acceptability of the intervention by both participants and their providers
Screen failure rate
Time Frame: Within 8 hours prior to cesarean delivery
Number of individuals who are eligible for the study but do not consent to participate
Trial retention rate
Time Frame: Up to 6 weeks after cesarean delivery
Frequency of participant completion of all study visits
Secondary Outcomes
- Surgical management of hemorrhage, inclusive of hysterectomy(During and up to 24 hours after cesarean delivery)
- Myocardial ischemia(During and up to 24 hours after cesarean delivery)
- Maternal hypotension(During and up to 6 hours after cesarean delivery)
- Intensive care unit admission(During and up to 24 hours after cesarean delivery)
- Readmission to the hospital or reoperation(Up to 6 weeks after cesarean delivery)
- Maternal flushing(During and up to 6 hours after cesarean delivery)
- Frequency of increase in oxytocin rate in low-dose arm(During and up to 6 hours after cesarean delivery)
- Additional use of uterotonics and/or tranexamic acid(During and up to 24 hours after cesarean delivery)
- Maternal nausea/vomiting(During and up to 6 hours after cesarean delivery)
- Quantitative blood loss greater than 1 liter(Within 24 hours after cesarean delivery)
- Need for blood product transfusion, inclusive of type and number of blood products transfused(Within 4 days after cesarean delivery)
- Placement of intrauterine balloon tamponade or suction device(During and up to 24 hours after cesarean delivery)
- Cardiac arrhythmia(During and up to 24 hours after cesarean delivery)
- Maternal death(During and up to 6 weeks after cesarean delivery)