Trials / Withdrawn
WithdrawnNCT06550089
High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth (HOLDOUT Pilot)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage. |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
- First posted
- 2024-08-12
- Last updated
- 2024-12-10
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06550089. Inclusion in this directory is not an endorsement.