Bracken, Hillary
Lightly, Kate
Mundle, Shuchita
Kerr, Robbie
Faragher, Brian
Easterling, Thomas
Leigh, Simon
Turner, Mark
Alfirevic, Zarko
Winikoff, Beverly
Weeks, Andrew http://orcid.org/0000-0002-1909-337X
Funding for this research was provided by:
medical research council (MR/R006/1801)
Article History
Received: 25 June 2021
Accepted: 19 July 2021
First Online: 29 July 2021
Declarations
:
: This trial underwent peer review as part of the funding process. It is sponsored by the University of Liverpool (Brownlow Hill, Liverpool L69 7ZX, UK; UoL001374) which oversees the study quality and has final responsibility for the study conduct. The study is also approved by the Institutional Ethics Committees at Government Medical College Nagpur (1724 EC/Pharmac/GMC/NGP), Spandan Heart Institute and Research Center (MOLI Study), and the Mahatma Gandhi Institute of Medical Sciences (MGIMS/IEC/OBGY/96/2020). The study is insured by the sponsor (for harm arising from protocol design) and by the recruiting sites (for clinical negligence). The study is registered with Clinical Trials.gov (NCT03749902) and Clinical Trial Registry, India (CTRI/2O W I A4l 0 I 8527). All women enrolled in the trial will provide informed written consent.
: Not applicable.
: Professor Andrew Weeks runs an information website called misoprostol.orgĀ on a voluntary basis. He also acts as a scientific advisor to Norgine. In this role he receives no personal remuneration other than travel expenses, but money is paid to the University of Liverpool for his time. The other authors declare that they have no competing interests.