CTRI/2009/091/000075CompletedNot Applicable
A randomised double- blind well controlled clinical trial to compare the efficacy and safety of rectally administered Misoprostol and Intravenous Oxytocin infusion in preventing intraoperative and postpartum blood loss in women undergoing caesarean section.
Chittaranjan Sevasadan HospitalSPMukherjee Road Kolkata1 site in 1 country0 target enrollmentStarted: January 12, 2007Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 1
- Primary Endpoint
- blood loss during operation and 8 hours postpartum and change in the hemoglobin 24 hours after delivery.
Study Overview
Brief Summary
This is a randomised ,double -blind, parallel group trial comparing the widely used intravenous Oxytocin infusion and rectally adminstered Misoprostol in low risk women undergoing caesarean section with a primary outcome measure of assessing the intraoperative and postpartum blood loss over next 8 hours and change in Hb%.Secondary outcome measures ,additional oxytocic requirement,need for blood transfusion,side effects and cost -efectiveness of the drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •women undergoing elective or emergency caesarean section.
Exclusion Criteria
- •Antepartum Haemorrhage,Severe Preeclampsia,Prolonged and Obstructed labour,Hb below 8gm/dl,Multiple Pregnancy,Polyhydramnios and associated Myoma of uterus,Cardiovascular,renal ,hepatic and connective tissue disorders.
Outcomes
Primary Outcomes
blood loss during operation and 8 hours postpartum and change in the hemoglobin 24 hours after delivery.
Time Frame: Blood loss:during operation and upto 8 hours postpartum. | Hb :predelivery and 24 hours after delivery.
Secondary Outcomes
- need for additional uterotonic, incidence of side effects and complications, need for blood transfusion and cost of oxytocic.(Upto 24 hours postpartum.)
Investigators
Study Sites (1)
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