A randomized control study to determine the efficacy of preoperative per rectal misoprostol in reducing blood loss in LSCS
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- DR SRINIDHI P M BHAT
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To study the effect of preoperative per rectal misoprostol in reducing intraoperative blood loss in lower segment cesarean section.
Overview
Brief Summary
This will be a randomized control trial spanning over 18 months, conducted in KIMS HUBLI. A total of 200 women meeting the inclusion criteria with written informed consent will be taken up for the study. Detailed history regarding gravida, parity, gestational age, presence of risk for PPH and other comorbidities and the indication for cesarean will be noted . Complete clinical and laboratory evaluation will be done. Eligible women will be randomized into 2 groups. Women in study group will receive 800mcg misoprostol per rectally immediately after spinal anesthesia. Caesarean delivery will be performed under spinal anesthesia by senior obstetricians who will be blind to allocation. 10 IU Oxytocin im will be administered intraoperative to both the groups as per the standard AMTSL practice .
Estimation of blood loss will be started after uterine incision. During the operation an isolated suction will be used for evacuation of amniotic fluid through a small incision over the uterus, and another one will be used for collection of blood. A dedicated assistant will be responsible for collection of blood and amniotic fluid in 2 separate suction sets, and for weighing surgical towels before and after operation. Gravimetric method will be used to determine the blood loss i.e the weight difference of 1gm between pre operative mops and post operative mops will be taken as 1 ml of blood loss. The collected blood in suction bottle would be added to the blood in clots and swabs. Blood loss will be calculated and compared in both. Preoperative and post operative hemoglobin and hematocrit values will be used to calculate the overall blood loss caused by the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Consenting women undergoing lower segment cesarean section in KIMS during study period.
Exclusion Criteria
- •Women known to have hypersensitivity to prostaglandin.
- •Medical contraindications for prostaglandin.
- •Women not consenting for trial.
Outcomes
Primary Outcomes
To study the effect of preoperative per rectal misoprostol in reducing intraoperative blood loss in lower segment cesarean section.
Time Frame: immediate post operative.48 hours post operatively
Secondary Outcomes
- To determine the use of pre operative misoprostol in reducing the incidence of PPH and there by reducing maternal mortality and morbidity.(2HRS AFTER LSCS)
Investigators
Srinidhi Bhat
Karnataka institute of medical science