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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Oxytocin is a synthetic molecule used to reduce the likelihood of postpartum hemorrhage.
Screen failure rate
Number of individuals who are eligible for the study but do not consent to participate
Time frame: Within 8 hours prior to cesarean delivery
Fidelity rate
Frequency of fidelity to the trial
Time frame: Within 8 hours prior to cesarean delivery
Trial retention rate
Frequency of participant completion of all study visits
Time frame: Up to 6 weeks after cesarean delivery
Acceptability of the intervention
Frequency of acceptability of the intervention by both participants and their providers
Time frame: Up to 6 weeks after cesarean delivery
Maternal flushing
Time frame: During and up to 6 hours after cesarean delivery
Maternal hypotension
Mean arterial blood pressure less than 65 mmHg
Time frame: During and up to 6 hours after cesarean delivery
Maternal nausea/vomiting
Time frame: During and up to 6 hours after cesarean delivery
Myocardial ischemia
Time frame: During and up to 24 hours after cesarean delivery
Cardiac arrhythmia
Time frame: During and up to 24 hours after cesarean delivery
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Quantitative blood loss greater than 1 liter
Time frame: Within 24 hours after cesarean delivery
Need for blood product transfusion, inclusive of type and number of blood products transfused
Time frame: Within 4 days after cesarean delivery
Frequency of increase in oxytocin rate in low-dose arm
Time frame: During and up to 6 hours after cesarean delivery
Additional use of uterotonics and/or tranexamic acid
Time frame: During and up to 24 hours after cesarean delivery
Placement of intrauterine balloon tamponade or suction device
Time frame: During and up to 24 hours after cesarean delivery
Surgical management of hemorrhage, inclusive of hysterectomy
Time frame: During and up to 24 hours after cesarean delivery
Intensive care unit admission
Time frame: During and up to 24 hours after cesarean delivery
Maternal death
Time frame: During and up to 6 weeks after cesarean delivery
Readmission to the hospital or reoperation
Time frame: Up to 6 weeks after cesarean delivery