Comparing oxytocin bolus and infusion for cesarean sections
Randomized Double-Blinded Clinical Trial of Oxytocin Bolus Versus Infusion in Elective Cesarean Section
This study tests whether giving oxytocin as a quick shot instead of a slow drip can help women having cesarean sections achieve better uterine tone and reduce bleeding.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT05236985 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of bolus administration of oxytocin compared to the standard infusion method in achieving adequate uterine tone during elective cesarean sections. Oxytocin is a key medication used to prevent postpartum hemorrhage, and this research aims to determine if a bolus approach can achieve uterine tone more quickly while minimizing adverse effects. The study will measure the time taken to achieve adequate uterine tone, estimated blood loss, and other related outcomes. Participants will include women aged 18 to 45 undergoing elective cesarean sections under spinal anesthesia.
Who should consider this trial
Good fit: Ideal candidates are parturients aged 18 to 45 with singleton pregnancies scheduled for elective cesarean sections.
Not a fit: Patients in labor, with multiple gestations, or those with specific risk factors for uterine atony will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of uterine tone during cesarean sections, reducing the risk of postpartum hemorrhage.
How similar studies have performed: Previous studies have suggested that bolus doses of oxytocin can be effective, but high-quality data comparing bolus versus infusion is limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parturients between the ages of 18 to 45 with singleton pregnancies * Undergoing elective cesarean section under spinal anesthesia * American Society of Anesthesia (ASA) physical status class I or II * Patients must be able to provide written informed consent Exclusion Criteria: * Parturients in labor or ruptured membranes * Multiple gestation * Risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids) * History of uterine atony or postpartum hemorrhage * History of inherited or acquired coagulation disorders, thrombocytopenia (platelet count \<100), or anemia (hemoglobin \< 8) * History of allergy to oxytocin * Patients not alert and orientated to person, place, and date. Patient must have, in the investigator's opinion, the physical and mental capacity to answer survey questions
Where this trial is running
Stony Brook, New York
- Stony Brook University — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Tiffany E Angelo, DO — Stony Brook University
- Study coordinator: Tifany E Angelo, DO
- Email: mailto:Tiffany.Angelo@stonybrookmedicine.edu
- Phone: 631-444-2975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.