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Clinical Trials/CTRI/2013/12/004193
CTRI/2013/12/004193Not yet recruitingNot Applicable

A randomized control trial comparing use of oxytocin bolus with and without oxytocin infusion in women with cesarean section after extraction of fetus

Dr RPGMC Kangra at Tanda HP1 site in 1 countryEnrollment: 80Started: December 15, 2013Last updated:
Conditions

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

Sponsor
Dr RPGMC Kangra at Tanda HP
Sponsor Class
Government medical college

Study Sites (1)

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Identifiers

CTRI ID
CTRI/2013/12/004193

Dates

Last updated
(13 years ago)