Elective Cesarean Section
Conditions
Keywords
Oxytocin, bolus, infusion
Brief summary
Bolus administration of oxytocin is superior to infusion in time to achieving adequate uterine tone.
Detailed 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.
Interventions
On the day of surgery, the patients will be randomized to either bolus or infusion administration of oxytocin. On the day of the procedure, periprocedural data and patient satisfaction (single question) will be recorded.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, double-blinded, 2-arm, parallel study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number/Proportion of Participants with Adequate Uterine tone | 2 minutes | Adequacy of uterine tone (yes/no) at 2 minutes after the baby is born/umbilical cord clamped. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied | 2± 1 hours after surgery | Patients will complete a questionnaire 2± 1 hours after surgery |
Countries
United States
Contacts
Primary ContactTifany E Angelo, DO
Backup ContactAyesha Khan
Outcome results
None listed