CompletedPhase 3ACTRN12614000870651

Carbetocin RTS for preventing postpartum haemorrhage: a randomized non-inferiority controlled trial.

A phase III, randomized, double-blind, active, controlled, multinational, multicentre, non-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally.


Sponsor

World Health Organization

Enrollment

30,000 participants

Start Date

Jul 7, 2015

Study Type

Interventional

Conditions

Summary

Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and it contributes to nearly a quarter of maternal deaths globally. The majority of deaths due to PPH could be avoided through the use of prophylactic uterotonics during the third stage of labour and by timely and appropriate management. Oxytocin (IM/IV, 10 IU) is recommended as the uterotonic drug of choice. Based on the manufacturer’s recommendations, oxytocin should be stored under refrigeration. Carbetocin appears to be a promising agent in the prevention of PPH, is a more stable molecule and induces a prolonged uterine response, when administered postpartum. The manufacturer of carbetocin (Ferring Pharmaceuticals) has recently developed a room temperature stable formulation (carbetocin RTS) which makes it an attractive option for countries where maintaining the cold chain is problematic. The World Health Organization would like to evaluate the room temperature stable carbetocin solution for injection as a promising intervention for reducing PPH particularly in settings where cold storage is difficult to achieve and maintain.


Eligibility

Sex: Females

Inclusion Criteria4

  • Women who are expected to deliver vaginally.
  • They have a cervical dilatation equal to or less than 6cm.
  • They provide written informed consent before any trial-related activities are carried out.
  • Known singleton pregnancy.

Exclusion Criteria10

  • Women will be excluded from participating in the trial if they are/have:
  • In an advanced first stage of labour (>6 cm cervical dilatation) or too distressed to understand, confirm and give informed consent regardless of cervical dilatation.
  • Non-emancipated minors (as per local regulations) without a guardian.
  • Scheduled for a planned caesarean section.
  • Birth considered an abortion according to local guidelines.
  • Allergic to carbetocin, other oxytocin homologues or excipients.
  • Serious cardiovascular disorders.
  • Not capable of giving consent due to other health problems such as obstetric emergencies (e.g. antepartum haemorrhage) or mental disorder.
  • Serious hepatic or renal disease
  • Epilepsy

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Interventions

Carbetocin RTS 100 micrograms solution for intramuscular (IM) injection to be administered once during the third stage of labour.

Carbetocin RTS 100 micrograms solution for intramuscular (IM) injection to be administered once during the third stage of labour.


Locations(10)

Rosario, Argentina

Assiut, Egypt

Belgaum, India

Nairobi, Kenya

Ibadan, Nigeria

Singapore, Singapore

Johannesburg, South Africa

Khon Kaen, Thailand

Kampala, Uganda

Birmingham, United Kingdom

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ACTRN12614000870651