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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Page 1 of 2 (5 locations)

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