Clotting parameters after medical abortion (C-PLAN)
Research type
Research Study
Full title
Measuring the changes in clotting parameters before and after medical abortion
IRAS ID
264304
Contact name
John J Reynolds-Wright
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
Venous thromboembolism (VTE - blood clots that form in deep veins or in the lungs) has been identified as a leading cause of death in economically developed countries for pregnant and recently-pregnant women. During pregnancy and in the time afterwards, clotting parameters (markers in the blood) can be out of normal range and indicate increased risk of clotting.
There is evidence that clotting parameters can take up to 6 weeks to return to normal for women who have had term deliveries, however there is an absence of information on time taken for clotting parameters to normalise following abortion. As such, existing guidelines are based solely on expert opinion and recommend durations of VTE prevention from as short as 7 days, up to 6 weeks following abortion.
All women are assessed for risk of VTE, but data are needed to inform an evidence-based approach to prevention of VTE in these women.
This pilot study will compare 4 groups of women: Group 1: Women undergoing medical abortion at gestations less than 10 weeks, Group 2: Women undergoing medical abortion at gestations 10-13 weeks and 6 days, Group 3: Women undergoing medical abortion at gestations 14-20 weeks. Group 4: Non-pregnant comparator group.
Blood tests will be obtained from women in Groups 1-3 just before their abortion and then again 10-14 days afterwards. Women in Group 4 will have one blood test.
These results will be compared to determine whether clotting parameters return to normal following medical abortion within 10-14 days and will inform a larger trial to investigate this further.When obtaining blood tests, NHS Lothian Lone Working and COVID-19 risk assessment policies will be adhered to.
REC name
North of Scotland Research Ethics Committee 2
REC reference
21/NS/0003
Date of REC Opinion
22 Feb 2021
REC opinion
Further Information Favourable Opinion