Dose of oxytocin needed during cesarean in patients with pregnancy of less than 37 weeks
- Conditions
- Encounter for cesarean delivery without indication,
- Registration Number
- CTRI/2023/05/053088
- Lead Sponsor
- University College of Medical Sciences and GTB Hospital
- Brief Summary
**Objective:**To evaluate and compare during cesarean delivery in patients with *preterm and term* pregnancy, the minimum effective dose (defined as ED90 i.e., dose expected to be adequate in 90% of target population) of prophylactic oxytocin infusion for achieving and maintaining adequate uterine tone.
**Methods:**This will be a dual-arm, dose finding study, based on biased coin sequential allocation design. The patient, anesthesiologist conducting the case, and obstetrician will be blinded to the dose of oxytocin. All women aged >18 years, and posted for cesarean delivery under spinal block will be evaluated for inclusion, either into the term (completed 37 weeks) or preterm (<37 weeks) cohort. Matching will be done in the preterm and term cohorts for categories of confounding variables known to affect association of oxytocin dose and uterine contraction.
***Oxytocin administration:***Oxytocin infusion will be initiated on clamping of the umbilical cord. The dose of the infusion will be 13 IU/h for the first patient in both cohorts. The designated hourly oxytocin dose will be added to normal saline in a 50 mL syringe, and infused via a syringe infusion pump at 50 mL/h. The dose in subsequent cases, for either cohort, will be determined by the response to oxytocin in previous patient of the particular cohort, based on biased sequential allocation method. The primary outcome measure is the adequacy of intraoperative uterine tone at 4 minutes and continued till the end of surgery, assessed by using 1 finger palpation method. When uterine tone is satisfactory, infusion of oxytocin will be continued till the end of surgery at the same rate. In case of an unsatisfactory tone, the infusion will be doubled and uterine massage initiated, followed by additional uterotonic is still required.
***Myometrial oxytocin receptor quantification:***Full thickness myometrial biopsy will be taken from the upper edge of the uterine transverse incision made for cesarean delivery. Routinely formalin fixed paraffin embedded myometrial tissue will then be used for immunohistochemistry using commercially available antibodies to evaluate myometrial oxytocin receptor density (using manufacturers’ instructions) in 10 out of 30 patients from each cohort.
***Other Observations:***These will include additional indications of efficacy of oxytocin, associated side effects and patients characteristics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 60
Posted for cesarean delivery under spinal block; either into the term or preterm cohort (defined as gestational age of completed 37 weeks (i.e., ≥259 days) or <37 weeks respectively.
Laboring with preoperative oxytocin use, or magnesium sulfate therapy, coagulopathy, history of previous uterine atony or postpartum hemorrhage or bleeding disorder or heart disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative uterine tone From 4 minutes of oxytocin initiation till end of surgery
- Secondary Outcome Measures
Name Time Method Need of additional uterotonic as per obstetrician, for inadequate uterine tone At ANY time during surgery (after initiating oxytocin to end of surgery)
Trial Locations
- Locations (1)
University College of Medical Science and GTB Hospital
🇮🇳East, DELHI, India
University College of Medical Science and GTB Hospital🇮🇳East, DELHI, IndiaDr Srishty SinglaPrincipal investigator9953489108srishty.singla11@gmail.com