Cesarean Section Complications, Postpartum Hemorrhage, Pregnancy Complications
Conditions
Keywords
oxytocin, cesarean delivery, postpartum hemorrhage
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
DRUGOxytocin
Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.
Sponsors
University of Chicago
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screen failure rate | Within 8 hours prior to cesarean delivery | Number of individuals who are eligible for the study but do not consent to participate |
| Fidelity rate | Within 8 hours prior to cesarean delivery | Frequency of fidelity to the trial |
| Trial retention rate | Up to 6 weeks after cesarean delivery | Frequency of participant completion of all study visits |
| Acceptability of the intervention | Up to 6 weeks after cesarean delivery | Frequency of acceptability of the intervention by both participants and their providers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac arrhythmia | During and up to 24 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 | — |
| 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 flushing | During and up to 6 hours after cesarean delivery | — |
| Surgical management of hemorrhage, inclusive of hysterectomy | During and up to 24 hours after cesarean delivery | — |
| Intensive care unit admission | During and up to 24 hours after cesarean delivery | — |
| Maternal death | During and up to 6 weeks after cesarean delivery | — |
| Readmission to the hospital or reoperation | Up to 6 weeks after cesarean delivery | — |
| Placement of intrauterine balloon tamponade or suction device | During and up to 24 hours after cesarean delivery | — |
| Maternal hypotension | During and up to 6 hours after cesarean delivery | Mean arterial blood pressure less than 65 mmHg |
| Maternal nausea/vomiting | During and up to 6 hours after cesarean delivery | — |
| Myocardial ischemia | During and up to 24 hours after cesarean delivery | — |
Outcome results
None listed