Deciding About Research During Childbirth (DARCi)
Research type
Research Study
Full title
Deciding About Research when heavy bleeding occurs during Childbirth (DARCi): A Study of Women’s Experiences
IRAS ID
170889
Contact name
Gillian Houghton
Contact email
Sponsor organisation
Liverpool Women's Hospital
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Research studies that examine treatments for life threatening conditions are essential to improve treatments available. Asking permission to involve a person in research at a time they are experiencing a life threatening emergency is difficult and the best way of approaching this is currently unclear.
The WOMAN Trial of Tranexamic Acid versus placebo for the management of PostPartum Haemorrhage (heavy bleeding after giving birth), has recently completed recruiting in the UK (IRAS Ref: 10\H0505\111). A range of methods were used to ask women whether they wanted to take part in this research, including retrospective consent. The WOMAN Trial was the first maternity research study in the UK that employed a process involving retrospective consent to enter women into research. In total 569 women were involved in the WOMAN Trial in the UK, 44 gave written consent at the time they were entered into the study, 525 women did not give written consent at the time they were entered, 520 agreed retrospectively to continue in the research and 5 were withdrawn. No complaints were received from any of the woman recruited by retrospective consent.
It is now critical that the views and opinions of the women involved in the WOMAN Trial are explored in depth.The VICTER study will use in depth interviews to assess the views of women recruited to the WOMAN Trial at one UK site, Liverpool. All 16 women who gave consent at the time they were experiencing a PPH will be invited, 22 of the 111 women who did not give consent at the time of the bleeding and who gave consent retrospectively will also be invited, as will the 2 women who declined written retrospective consent. The knowledge gained will be essential in planning future research studies in a way that is most acceptable to women.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0190
Date of REC Opinion
19 Mar 2015
REC opinion
Favourable Opinion