Venous Thromboembolism Clinical Trial
— C-PLANOfficial title:
Measuring the Changes in Clotting Parameters Before and After Medical Abortion
NCT number | NCT04824118 |
Other study ID # | AC20164 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 26, 2021 |
Est. completion date | August 12, 2021 |
Verified date | April 2022 |
Source | NHS Lothian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 12, 2021 |
Est. primary completion date | August 12, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: 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 - Able to speak English independently Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chalmers Centre for Sexual and Reproductive Health | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian | University of Edinburgh |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clotting Time in Seconds | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Primary | Clot Formation Time in Seconds | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Primary | Maximal Amplitude in millimeters | On clotting curve as measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Primary | Maximum Lysis of clot in percentage | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Primary | Clot Lysis index in percentage | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Primary | Lysis time in seconds | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Secondary | Prothrombin Time in seconds | Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4. | 10-14 days | |
Secondary | Activated Partial Thromboplastin Time in seconds | Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4. | 10-14 days | |
Secondary | International Normalised Ratio (INR) | Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4. | 10-14 days | |
Secondary | Fibrinogen in grams per litre | Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4. | 10-14 days | |
Secondary | Platelet count (x10^9 per litre) | Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4. | 10-14 days | |
Secondary | Thromboelastography parameters (comparison with non-pregnant group) | Comparison of thromboelastography parameters (as measured using ClotPro device) between Groups 1-3 with Group 4. | 10-14 days | |
Secondary | Serum hCG in units per litre | Comparison of serum hCG levels between baseline and follow up in groups 1-3 | 10-14 days | |
Secondary | Lysis time in seconds | As measured using ClotPro device between baseline and follow up for Groups 1-3. | 10-14 days | |
Secondary | Clot Lysis index in percentage | As measured using ClotPro device comparing Groups 1-3 with Group 4 | 10-14 days | |
Secondary | Maximum Lysis of clot in percentage | As measured using ClotPro device comparing Groups 1-3 with Group 4 | 10-14 days | |
Secondary | Maximal Amplitude in millimeters | As measured using ClotPro device comparing Groups 1-3 with Group 4. | 10-14 days | |
Secondary | Clot Formation Time in Seconds | As measured using ClotPro device comparing Groups 1-3 with Group 4 | 10-14 days | |
Secondary | Clotting Time in Seconds | As measured using ClotPro device comparing Groups 1-3 with Group 4 | 10-14 days |
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