1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  By personal mail to the study investigators: Dr Shivaprasad S Goudar (sgoudar@jnmc.edu) and Dr Mariana Widmer (widmerm@who.int)


6. For how long will this data be available start date provided 01-09-2027 and end date provided 31-08-2032?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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 20 tertiary level hospitals within Argentina, Kenya, India, Nigeria, Uganda, South Africa, and United Kingdom. Recruitment for the trial will occur over 30 months.

An initial, internal, comparative safety sub-study is embedded in this trial to robustly evaluate the comparative effects of HSC versus oxytocin on specific haemodynamic outcomes. The safety sub-study will enroll 250 women and will be conducted in selected hospitals in Argentina, South Africa and United Kingdom. An independent Data Safety Monitoring Committee (DSMC) will examine the results from the interim analysis of this safety sub-study and make recommendations on whether to progress to full-scale trial.

Update as on 25 April 2026

On behalf of the Study Sponsor, there has been a decision taken to Close out the recruitment for trial at the Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India – 221005 due to the reasons as detailed:  

The application for renewal of the Ethics Committee (EC) registration for the IMS Banaras Hindu University, Varanasi site was submitted at a later stage. Following submission, queries were raised by the licensing authority; however, the responses provided did not meet the required expectations, and the EC registration was therefore not renewed.

Subsequent to this, request letters from the Site PI, Dr Uma Pandey, seeking review and approval of the amended protocol were submitted twice to the Ethics Committee, and receipt of the submissions was acknowledged. However, in Dec 2025, the Ethics Committee Member Secretary communicated that since the Ethics Committee renewal was incomplete and the registration had expired in May 2025, the Committee was unable review the protocol amendment or provide Ethical oversight for the implementation of the trial.

Accordingly, in consultation with the Sponsor, a decision was taken to place enrolment at the site on hold, effective January 9, 2026.

Further, after the enrolment had remained on hold for more than two months, it was learnt that the Institute had applied for the registration of a new Ethics Committee, which was still under review.

Considering the ongoing lack of ethical oversight, a decision was taken to close out the site. Accordingly, the Site has been closed out from 30 March 2026.

The information regarding the Site Closeout has also been notified to the Drugs Controller General (India).