The PERIOD study

• Research type

  Research Study

• Full title

  Abnormal uterine bleeding in women PrescribEd anticoagulant theRapy – understandIng wOmen’s experiences and Developing a consensus on management

• IRAS ID

  270321

• Contact name

  Jignesh. P Patel

• Contact email

  jig.patel@kcl.ac.uk

• Sponsor organisation

  King's College London

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  Aim
  To understand the impact blood thinning medication has on women’s periods and quality of life and to develop agreement among experts on how this should be managed.

  Background
  Blood thinning medication (anticoagulants) are prescribed for women who suffer a clot in the veins of their legs or in the blood vessels of their lungs. When this occurs, treatment is given for a minimum of 3-6 months.
  Although it is expected that anticoagulants will make the periods of women heavier, little research has been conducted around this, particularly how much more bleeding occurs in women prescribed anticoagulants. Four new anticoagulant tablets - DOACs, are now available. They are now the first line treatment for bloods clots, but reports that these medicines cause heavier periods than warfarin did in the past have emerged.

  Methodology
  We will conduct three studies.
  The first, will explore women’s experiences of bleeding during two consecutive periods, using two approved questionnaires. Two groups of women will be recruited: (i) women not prescribed any form of blood thinning medication, (ii) women prescribed a DOAC. In this way, we will be able to understand how period bleeding differs between the groups.

  The second study will ask a group of expert doctors, to review a number of cases representing the nature of the clinical problem forming the focus of this research. These experts will be asked to reach agreement on how each case should be managed.

  The final study will further examine the specific experiences of women who experience heavy bleeding during their periods, by undertaking in-depth interviews of women from each group from study I. In this way, the
  problem will be better understood and as part of this, whether the management options generated from study II would be acceptable to women.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  19/SW/0211

• Date of REC Opinion

  5 Nov 2019

• REC opinion

  Further Information Favourable Opinion