EUCTR2014-001948-37-GB
Active, not recruiting
Phase 1
Intramuscular oxytocics: A multi-centre randomised comparison study of intramuscular Carbetocin, Syntocinon and Syntometrine for the third stage of labour following vaginal birth - IMox study
orth Bristol NHS Trust0 sites6,285 target enrollmentSeptember 30, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orth Bristol NHS Trust
- Enrollment
- 6285
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 18 years of age, or older, at time of delivery
- •\- Singleton pregnancy
- •\- Vaginal birth (spontaneous and instrumental)
- •\- Any gestation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 6285
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •\- Significant antepartum haemorrhage (\>50ml) or suspected or proven placenta abruption
- •\- Maternal coagulation disorder
- •\- Multiple pregnancy (twins or higher order)
- •\- Intrauterine fetal death
- •\- Patients who would decline blood products if required (ie: Jehovah's Witnesses \- clinicians may have a lower threshold for administering additional prophylactic uterotonic drugs to these patients)
- •\- Known or suspected hypertensive disorders, including pre\-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled), and patients with hypertension in labour
- •\- Patients with peripheral, hepatic or cardiac disease
- •\- Patients with an allergy or hypersensitivity to any of the active ingredients in Carbetocin, Syntometrine or Syntocinon
Outcomes
Primary Outcomes
Not specified
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