None listed
Conditions
Brief summary
This study seeks to find out whether giving an injection into the thigh (called Syntometrine - a combination of two uterus-contracting drugs) after an emergency caesarean section delivery will reduce the rate of excessive bleeding after childbirth. This study will randomly assign participants to receive either Syntometrine or a placebo. Both groups will receive normal care (i.e. standard uterus contracting medications). Our hypothesis is that it will reduce the rate of bleeding, and be well tolerated.
Interventions
Intervention arm: Single dose of intramuscular Syntometrine (500 mcg Ergometrine, 5 IU Oxytocin, 1mL, Thigh) in addition to standard care of 5 IU oxytocin IV plus IV infusion of 10 IU oxytocin per hour for 4 hours.
Administered immediately after Emergency caesarean section.
Sponsors
Dr Russell Dalton
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Adult patients (greater than or equal to 18 years of age) - Women - Singleton Pregnancy - Undergoing an Emergency Caesarean section
Exclusion criteria
- Planning an elective caesarean section delivery - Current use of anticoagulant agents - Past history of a bleeding diathesis - Contraindications to study drug o Known allergy to Syntometrine, oxytocin, ergometrine, acetic acid, chlorobutanol hemihydrate, maleic acid, or sodium acetate trihydrate o Severe hypertension, pre-eclampsia, or eclampsia o Severe cardiac disorders o Hepatic or renal impairment o Occlusive vascular disease o Sepsis o Concurrent use of clarithromycin, erythromycin, HIV protease or reverse transcriptase inhibitors, or azole antifungals
Outcome results
None listed