A randomized control trial comparing use of oxytocin bolus with and without oxytocin infusion in women with cesarean section after extraction of fetus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The primary outcome is major obstetrical hemorrhage following caesarean section. (defined as blood loss 1000ml ).
Study Overview
Brief Summary
80 women for emergency cesarean section will be randomized in to two groups after fulfillment of inclusion and exclusion criteria. Group 1 will receive 3 IU oxytocin bolus and group 2 will receive 3 ml of placebo (0.9% normal saline solution), after delivery of fetus and clamping of umbilical cord. All women will receive oxytocin infusion @ 40 mU/min. All women will receive 2 ml (0.5%) bupivacaine intra-thecally in L3-L4. These women will be compared for obstetrical hemorrhage, hemodynamic profile (BP, Pulse rate, Mean arterial pressure), > 20% fall in hematocrit, need for blood transfusion, side effect profile, duration of surgery and need for manual removal of placenta.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Randomization method
- Computer generated randomization
- Masking
- Double Blind Double Dummy
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Singleton pregnancy/Woman for emergency caesarean section as per obstetrical indication/Period of gestation between 36 to 41 weeks.
Exclusion Criteria
- •Twin pregnancy /severe pre-eclampsia/ HELLP syndrome/Co-agulopathy/Abruptio placentae/Intra-uterine fetal death/Malformed fetus/Uncontrolled diabetes mellitus/Chorio-amniotis/Known case of thrombophilia/ Known case of chronic Renal or liver disease /previous classical caesarean section/ hysterotomy/previous uterine surgery (caesarean section, myomectomy, hysterotomy, polypectomy, lysis of uterine synechia, or hysteroscopic metroplasty).
Outcomes
Primary Outcomes
The primary outcome is major obstetrical hemorrhage following caesarean section. (defined as blood loss 1000ml ).
Time Frame: 24 hours after LSCS
PRIMARY OUTCOME
Time Frame: 24 hours after LSCS
Secondary Outcomes
- •Hemodynamic profile ( BP, mean arterial pressure, pulse rate)(•Severe anemia ( 20% fall in Hb post operative))
Investigators
Study Sites (1)
Identifiers
- CTRI ID
- CTRI/2013/12/004193
Dates
- Last updated
- (13 years ago)
