DOACs Qualitative Study v.1.0
Research type
Research Study
Full title
Understanding the factors influencing participation in a clinical study of direct oral anticoagulants (DOACs) among breastfeeding women:a qualitative study
IRAS ID
218089
Contact name
Yating Zhao
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
Venous thromboembolism (VTE) is the formation of blood clots in human's body. It has a relatively increased incidence in women following the birth of a baby. So mothers identified at significant risk of VTE or diagnosed with VTE are prescribed 'blood thinning'medications - anticoagulants. In recent year, new anticoagulants have become available. These new anticoagulants are called DOACs. They have many advantages over traditional anticoagulants which require women to inject, and/or attend clinic for blood monitoring. However, it is not known whether these DOACs transfer into breast milk.
We are designing a clinical trial to provide valuable information on the use of these DOACs in breastfeeding women. It will be a major challenge to recruit breastfeeding women as they are special population who are generally excluded from clinical trials. Prior to finalising our proposed clinical trial, we will conduct this focus group study to elicit information regarding their consenting issues, concerns and expectations to the proposed clinical trial, with the aim of improving the recruitment strategies and the management of our proposed clinical trial(DOACs Excretion into Breast Milk).
This focus group study will consist of 3 sub-groups (4-5 participants in each group). All participants are women who have had breastfeeding experience within the past 5 years or who are breastfeeding currently. Participants will be asked to discuss their opinions with an open-ended question guide focusing on perceptions and concerns related to clinical trials and our proposed clinical trial . All conversations in the focus group will be audio-taped. Each focus group will last approximately 1 hour, and will be conducted in King's College Hospital.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0015
Date of REC Opinion
25 Jan 2017
REC opinion
Further Information Favourable Opinion