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
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,)