Clinical Trials Logo

Clinical Trial Summary

Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.


Clinical Trial Description

Oxytocin is the most commonly used uterotonic agent worldwide to achieve adequate uterine tone and prevent postpartum hemorrhage. Over the past decade, the trend has been towards lowering the dose to reduce oxytocin-related adverse effects including nausea, hypotension, chest pain, EKG changes, and maternal death. However, the optimal strategy for oxytocin administration remains controversial. Prior literature found bolus doses less than 5 IU to be effective in achieving adequate uterine tone with a significant reduction in adverse side effects. There is limited high quality data comparing bolus versus infusion administration of oxytocin. The current standard of care at the institution is an infusion of oxytocin 18 IU/hour (0.3 IU/min) and has been proven to be effective in achieving adequate uterine tone. However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method. Given that the estimated uterine blood flow is between 500-700 mls/min, the uterus can lose a significant amount of blood per second if uterine tone is not achieved quickly. Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section. The primary objective of this study is to test the hypothesis that administration by bolus (vs. standard of care infusion) results in more rapid achievement of adequate uterine tone. Secondary objectives include determining estimated blood loss, prevalence of hypotension, nausea, vomiting, and patient satisfaction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05236985
Study type Interventional
Source Stony Brook University
Contact Tifany E Angelo, DO
Phone 631-444-2975
Email mailto:Tiffany.Angelo@stonybrookmedicine.edu
Status Recruiting
Phase Phase 4
Start date March 15, 2022
Completion date December 15, 2024

See also
  Status Clinical Trial Phase
Completed NCT04083768 - Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia N/A
Active, not recruiting NCT01234662 - Influence of Surgical Regional Anesthesia on Postoperative Pain N/A
Completed NCT00474162 - The Clotting Effects of Pentastarch and Normal Saline in Obstetric Patients N/A
Terminated NCT00330512 - Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome. Phase 1
Completed NCT03853694 - Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section Phase 4
Completed NCT01248078 - Antibiotic Prophylaxis Before Surgery Versus After Cord Clamping in Elective Cesarean Delivery - a Double-blind, Prospective, Randomized Placebo-controlled Trial N/A
Completed NCT01862432 - Immediate Skin-to-skin Contact After C-section N/A
Completed NCT04370847 - Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section
Recruiting NCT06155968 - Evaluating The Quality of Recovery After Elective Cesarean Section N/A
Completed NCT03549884 - Delayed Cord Clamping in Infants Born by Cesarean Section N/A
Completed NCT03507387 - Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia N/A