Skip to main content
Clinical Trials/CTRI/2017/11/010496
CTRI/2017/11/010496CompletedPhase 4

Efficacy of different infusion rates of oxytocin for maintaining uterine tone during non-elective caesarean section in labouring patients– a randomized, double-blind controlled trial

University College of Medical Sciences and GTB Hospital1 site in 1 country105 target enrollmentStarted: November 21, 2017Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
105
Locations
1
Primary Endpoint
Estimated blood loss during intraoperative period

Study Overview

Brief Summary

Spinal anaesthesia will be administered as per standard protocol. At thetime of clamping the umbilical cord, oxytocin 3 U will be administered i.v.over a period of 1 min to all the patients. Immediately after this injection,oxytocin infusion will be started at a rate depending on group allocation viz.2.5 IU/hr or 5 IU/hr or 10 IU/hr. Inadequate uterine tone will be managed with maximum of two rescue doses of oxytocin and carboprost thereafter, if required.

Estimated blood loss, adequacy of uterine tone, need for additional uterotonics, change in haemoglobin level at 4 and 24 hours, and any oxytocin related side-effects will be assessed.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Healthy females with 37 weeks or more gestation, Uncomplicated, singleton pregnancy, Labouring patients who have received oxytocin for induction or augmentation of labour.

Exclusion Criteria

  • Known drug allergy to oxytocin, Maternal complications e.g. pre-eclampsia, diabetes mellitus, cardiovascular disease, cerebrovascular disease, bronchial asthma, Known risk factors for postpartum haemorrhage e.g. Multiple gestation, abnormal placentation, uterine fibroid, macrosomia, hydramnios, history of postpartum haemorrhage or uterine atony.

Outcomes

Primary Outcomes

Estimated blood loss during intraoperative period

Time Frame: Estimated blood loss during intraoperative period

Secondary Outcomes

  • Adequacy of uterine tone,(Need for additional uterotonics,)

Investigators

Sponsor
University College of Medical Sciences and GTB Hospital
Sponsor Class
Government medical college

Study Sites (1)

Loading locations...

Similar Trials