A66045_REACH_Heat-stable carbetocin for the treatment of postpartum haemorrhage

• Research type

  Research Study

• Full title

  Heat-stable carbetocin for the treatment of postpartum haemorrhage: a phase III, randomized, double-blind, active controlled, multicountry, multicentre, non-inferiority trial

• IRAS ID

  1009137

• Contact name

  Olufemi Oladapo

• Contact email

  oladapoo@who.int

• Sponsor organisation

  World Health Organization

• Research summary

  This is a phase III, randomised, double-blind, multicentre, international trial aiming to evaluate the efficacy and safety of heat-stable carbetocin (HSC) for treatment of postpartum haemorrhage (PPH) in women who have had a vaginal birth. 6,200 participating women with vaginal births who have received HSC as prevention for PPH, will be randomised to receive either intravenous HSC or oxytocin as the ‘first-line’ PPH treatment. Once administered, the clinical staff will continue further PPH management in accordance with existing hospital PPH management protocol and WHO guidelines.
  All women will be followed up for 24 hours after randomisation or until hospital discharge, whichever is soonest.
  The trial will be conducted across Argentina, Kenya, India, Nigeria, Uganda, South Africa, and United Kingdom. Recruitment for the trial will occur over 30 months.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  24/WM/0018

• Date of REC Opinion

  20 Feb 2024

• REC opinion

  Further Information Favourable Opinion