Glycerine Trinitrate for Retained Placenta (GOT-IT Trial)
Research type
Research Study
Full title
A pragmatic group sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta (GOT-IT Trial)
IRAS ID
131556
Contact name
Fiona Charlotte Denison
Contact email
Sponsor organisation
University of Edinburgh (ACCORD)
Eudract number
2013-003810-42
ISRCTN Number
N/A
Research summary
We want to find out whether glyceryl trinitrate (GTN) is effective in treating a stuck or retained placenta (RP) after a woman has had a vaginal delivery. A RP occurs when the placenta fails to deliver after a baby is born. If the placenta is not delivered, women can bleed heavily. We are looking to see whether GTN reduces the need for women to have their placenta removed in an operating theatre by an operation called Manual Removal Of Placenta (MROP). This is the only treatment currently available for women with a RP. We plan to do this by comparing women who have GTN or a placebo (dummy drug that contains no treatment) in a multi-centre randomised clinical trial involving at least 20 delivery units in the UK (GOT-IT Trial).
The GOT-IT Trial will be carried out in 2 phases. The first phase will involve an internal pilot study where the aim will be to test out and refine trial procedures in a small number of hospital sites. Women who take part, those who decline to take part, and health care professionals who have worked on the trial will be invited to take part in a qualitative interview to talk about their experiences. The aim of these interviews will be to refine and improve trial processes such as gaining consent. The second phase will be the main trial where recruitment will be extended to a larger number of hospitals (at least 20 delivery units in the UK) in order to determine clinical effectiveness (does it work) and cost effectiveness (does it reduce costs).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0339
Date of REC Opinion
22 Jan 2014
REC opinion
Further Information Favourable Opinion