Status:
COMPLETED
Intramuscular Oxytocics: A Randomised Control Trial
Lead Sponsor:
North Bristol NHS Trust
Collaborating Sponsors:
Ferring Pharmaceuticals
University of Bristol
Conditions:
Post Partum Haemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after the birth, "post-partum haemorrhage" (PPH). In the UK, PPH affects approx 10% of new mothers. PPH can be f...
Detailed Description
BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to excessive bleeding after the birth of the baby and placenta, or "post-partum haemorrhage" (PPH). In the UK...
Eligibility Criteria
Inclusion
- ≥18 years of age at time of delivery
- Singleton pregnancy
- Vaginal birth (spontaneous and instrumental)
- \>24 weeks gestation
Exclusion
- Significant APH (\>50ml) or suspected or proven placenta abruption
- Maternal coagulation disorder
- Intrauterine fetal death
- Patients who would decline blood products if required
- Known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled)
- Hypertension in labour, or patients who have not had their blood pressure checked 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
- Epilepsy
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2018
Estimated Enrollment :
5798 Patients enrolled
Trial Details
Trial ID
NCT02216383
Start Date
February 1 2015
End Date
October 30 2018
Last Update
November 14 2018
Active Locations (5)
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1
North Bristol NHS Trust
Bristol, Avon, United Kingdom, BS10 5NB
2
Gloucestershire Hospitals NHS Trust
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
3
Royal United Hospital NHS Trust
Bath, Somerset, United Kingdom, BA1 3NG
4
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom