Clotting Parameters After Medical Abortion
C-PLAN
Measuring the Changes in Clotting Parameters Before and After Medical Abortion
1 other identifier
observational
45
1 country
1
Brief 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. 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. The findings from this pilot study have the potential to inform clinical guidance and possibly a larger study subsequently.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2020
CompletedStudy Start
First participant enrolled
March 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2021
CompletedApril 20, 2022
April 1, 2022
5 months
December 7, 2020
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Clotting Time in Seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Clot Formation Time in Seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Maximal Amplitude in millimeters
On clotting curve as measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Maximum Lysis of clot in percentage
As measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Clot Lysis index in percentage
As measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Lysis time in seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
10-14 days
Secondary Outcomes (13)
Prothrombin Time in seconds
10-14 days
Activated Partial Thromboplastin Time in seconds
10-14 days
International Normalised Ratio (INR)
10-14 days
Fibrinogen in grams per litre
10-14 days
Platelet count (x10^9 per litre)
10-14 days
- +8 more secondary outcomes
Study Arms (4)
Group 1: Gestation less than 10 weeks
Blood tests and urine sample at baseline and 10-14 days after mifepristone administration
Group 2: Gestation 10-14 weeks
Blood tests and urine sample at baseline and 10-14 days after mifepristone administration
Group 3: Gestation 14-20 weeks
Blood tests and urine sample at baseline and 10-14 days after mifepristone administration
Group 4: Non-pregnant controls
Blood tests at baseline only.
Interventions
Point of Care Test for clotting parameters (ClotPro device)
Standard laboratory tests for clotting: * International normalised ratio (INR) * Prothrombin time (PT) * adjusted partial thromboplastin time (aPTT) * fibrinogen
For platelet count
Serum human chorionic gonadotrophin
Eligibility Criteria
Women seeking medical abortion at various gestations and non-pregnant comparator group.
You may qualify if:
- Group 1:
- Pregnant and seeking abortion
- Gestation of pregnancy less than 10 weeks
- Healthy, no medical conditions
- Group 2:
- Pregnant and seeking abortion
- Gestation of pregnancy between 10 and 14 weeks
- Healthy, no medical conditions
- Group 3:
- Pregnant and seeking abortion
- Gestation of pregnancy between 14 to 20 weeks
- Healthy, no medical conditions
- Group 4:
- Non pregnant
- Healthy, no medical conditions
- +1 more criteria
You may not qualify if:
- All groups:
- Unable to give informed consent
- Previous or current venous thromboembolism
- Current smoker
- Personal or family history of thrombophilia or haemophilia
- Taking medicines known to affect clotting parameters (e.g. Aspirin)
- Groups 1-3:
- \- Planning to commence hormonal contraception prior to second blood test.
- Group 4:
- \- Using hormonal contraception at baseline visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Lothianlead
- University of Edinburghcollaborator
Study Sites (1)
Chalmers Centre for Sexual and Reproductive Health
Edinburgh, EH39ES, United Kingdom
Biospecimen
Blood samples - testing for clotting factors Urine - point of care pregnancy test
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John J Reynolds-Wright, MBChB
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2020
First Posted
April 1, 2021
Study Start
March 26, 2021
Primary Completion
August 12, 2021
Study Completion
August 12, 2021
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
As this is abortion-care research with small numbers of participants, we will not make individual level participant data available publicly. Should researchers required this data for meta-analysis (for example) they can contact the principle investigator and request will be considered on a case-by-case basis.