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Clinical Trials/CTRI/2024/10/075280
CTRI/2024/10/075280
Not yet recruiting
Phase 3

A randomized control study to determine the efficacy of preoperative per rectal misoprostol in reducing blood loss in LSCS

DR SRINIDHI P M BHAT1 site in 1 country200 target enrollmentStarted: October 28, 2024Last updated:

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

Sponsor
DR SRINIDHI P M BHAT
Sponsor Class
Other [Self funded]
Responsible Party
Principal Investigator
Principal Investigator

Srinidhi Bhat

Karnataka institute of medical science

Study Sites (1)

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