Abortion EarlyC-PLANNCT04824118
Clotting Parameters After Medical Abortion
An observational study of Abortion Early and Abortion, Complete, run by NHS Lothian at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early, Abortion, Complete, Abortion, Second Trimester
- What is being tested?
- Thromboelastometry, Clotting Studies and Full Blood Count
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2021to 12 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women seeking medical abortion at various gestations and non-pregnant comparator group.
Who may be able to join
- Group 1:
- Pregnant and seeking abortion
- Gestation of pregnancy less than 10 weeks
- Healthy, no medical conditions
- Group 2:
- Pregnant and seeking abortion
Show all 16Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- Groups 1-3:
- Planning to commence hormonal contraception prior to second blood test.
- Group 4:
- Using hormonal contraception at baseline visit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chalmers Centre for Sexual and Reproductive Health
Edinburgh, EH39ES
About this study
Official title: Measuring the Changes in Clotting Parameters Before and After Medical Abortion
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.
Read more
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.
Read the detailed description
Sample population: Women who attend the abortion service at the Chalmers Centre to receive abortion assessment and abortion care. There will be 3 groups recruited based upon gestational age of pregnancy - Group 1: Gestation less than 10 weeks (10 participants), Group 2: Gestation 10+0 -13+6 weeks (10 participants), Group 3: Gestation 14+0-20+0 weeks (10 participants).
Information Sheet: All new patients attending the clinic will be given a copy of the participant information sheet, so that they have time to read about the study. The Information sheet will also be available on the 'research' section of the clinic website - all women are routinely directed to this page before attending clinic.
Approach by research staff: Following registration, all patients are taken for an ultrasound scan by a clinical support worker to confirm gestation. Following this, patients move to a waiting area until they can be seen for their assessment. While they are waiting, the clinic coordinator will ask the patient if they are happy to be approached by the researcher to discuss the study further. If they are happy to discuss further, the researcher will then approach and discuss the study in a private room.
Consent: If patients are happy to participate in the study, the researcher will then obtain written informed consent prior to their bloods being taken by clinic staff if bloods required for routine care, if no routine bloods are required, the researcher will obtain the blood sample. Participants will be asked if they are planning to use a hormonal form of contraception following their abortion - if yes, they would be asked to wait until they have had their second blood sample taken to commence or not taken forward into the study.
First blood test: This will be obtained on the day of clinic attendance and ultrasound scan. Blood samples (less than 20 ml) will be obtained and taken to the NHS Lothian laboratory at the Royal Infirmary of Edinburgh and for ClotPro thromboelastography point of care testing.
Second blood test: An appointment will be made to see the patient in Chalmers Centre or at their home to obtain a further blood sample to compare to the initial test. This will take place 10-14 days following mifepristone administration. For the repeat sample we will conduct a COVID-19 risk assessment and only invite them for return visit/home visit if:
- The participant has confirmed they and close contacts are well and without suspicion of COVID-19.
- The participant agrees to a home visit.
- The research staff undertaking the home visit should be well and have had no known contact with a COVID-19 positive individual for the past 14 days.
If they are having an intrauterine contraceptive, implant or injection, the second blood sample can be taken when they come into clinic for this, to minimise the number of visits.
Comparison group: A comparison group, Group 4 (10 participants), who are healthy volunteers, recruited from sexual and reproductive health clinics at Chalmers Centre, will be asked to provide a single blood test for ClotPro and lab tests, and urine pregnancy test hCG to act as a nonpregnant comparison. These participants must not be using hormonal contraception and must not be pregnant. This group will be approached by clinicians working in the SRH clinics and the researcher will be on hand to obtain consent and then draw blood.
- Conditions
- Abortion Early, Abortion, Complete, Abortion, Second Trimester, Termination of Pregnancy Complicated by Embolism, Venous Thromboses, Venous Thromboembolism
- Being tested
- Thromboelastometry, Clotting Studies, Full Blood Count, Quantitative hCG, Pregnancy Test
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastometryDiagnostic test
Point of Care Test for clotting parameters (ClotPro device)
Clotting StudiesDiagnostic test
Standard laboratory tests for clotting:
- International normalised ratio (INR)
- Prothrombin time (PT)
- adjusted partial thromboplastin time (aPTT)
- fibrinogen
Full Blood CountDiagnostic test
For platelet count
Quantitative hCGDiagnostic test
Serum human chorionic gonadotrophin
Pregnancy TestDiagnostic test
Point of care urinary pregnancy test
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Gestation less than 10 weeks | Blood tests and urine sample at baseline and 10-14 days after mifepristone administration Receives: Diagnostic Test: Thromboelastometry; Diagnostic Test: Clotting Studies; Diagnostic Test: Full Blood Count; Diagnostic Test: Quantitative hCG | |
| Group 2: Gestation 10-14 weeks | Blood tests and urine sample at baseline and 10-14 days after mifepristone administration Receives: Diagnostic Test: Thromboelastometry; Diagnostic Test: Clotting Studies; Diagnostic Test: Full Blood Count; Diagnostic Test: Quantitative hCG | |
| Group 3: Gestation 14-20 weeks | Blood tests and urine sample at baseline and 10-14 days after mifepristone administration Receives: Diagnostic Test: Thromboelastometry; Diagnostic Test: Clotting Studies; Diagnostic Test: Full Blood Count; Diagnostic Test: Quantitative hCG | |
| Group 4: Non-pregnant controls | Blood tests at baseline only. Receives: Diagnostic Test: Thromboelastometry; Diagnostic Test: Clotting Studies; Diagnostic Test: Full Blood Count; Diagnostic Test: Pregnancy Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting Time in Seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Clot Formation Time in Seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Maximal Amplitude in millimeters
On clotting curve as measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Maximum Lysis of clot in percentage
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Clot Lysis index in percentage
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Lysis time in seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Secondary outcomes (13)
Prothrombin Time in seconds
Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4.
Measured: 10-14 days
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.
Measured: 10-14 days
International Normalised Ratio (INR)
Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4.
Measured: 10-14 days
Fibrinogen in grams per litre
Assessed by laboratory tests between baseline and follow up in Groups 1-3 and in comparison with group 4.
Measured: 10-14 days
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.
Measured: 10-14 days
Thromboelastography parameters (comparison with non-pregnant group)
Comparison of thromboelastography parameters (as measured using ClotPro device) between Groups 1-3 with Group 4.
Measured: 10-14 days
Serum hCG in units per litre
Comparison of serum hCG levels between baseline and follow up in groups 1-3
Measured: 10-14 days
Lysis time in seconds
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Measured: 10-14 days
Clot Lysis index in percentage
As measured using ClotPro device comparing Groups 1-3 with Group 4
Measured: 10-14 days
Maximum Lysis of clot in percentage
As measured using ClotPro device comparing Groups 1-3 with Group 4
Measured: 10-14 days
Maximal Amplitude in millimeters
As measured using ClotPro device comparing Groups 1-3 with Group 4.
Measured: 10-14 days
Clot Formation Time in Seconds
As measured using ClotPro device comparing Groups 1-3 with Group 4
Measured: 10-14 days
Clotting Time in Seconds
As measured using ClotPro device comparing Groups 1-3 with Group 4
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 Mar 2021
- Primary completion12 Aug 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- John J Reynolds-Wright, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824118
- Sponsor's protocol ID
- AC20164
- Acronym
- C-PLAN
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Changes in Clotting Parameters Before and After Medical Abortion
- ClinicalTrials.gov ID
- NCT04824118
- Acronym / sponsor ID
- C-PLAN / AC20164
- Conditions
- Abortion Early, Abortion, Complete, Abortion, Second Trimester, Termination of Pregnancy Complicated by Embolism, Venous Thromboses, Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- University of Edinburgh
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- 12 Aug 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample population: Women who attend the abortion service at the Chalmers Centre to receive abortion assessment and abortion care. There will be 3 groups recruited based upon gestational age of pregnancy - Group 1: Gestation less than 10 weeks (10 participants), Group 2: Gestation 10+0 -13+6 weeks (10 participants), Group 3: Gestation 14+0-20+0 weeks (10 participants).
Information Sheet: All new patients attending the clinic will be given a copy of the participant information sheet, so that they have time to read about the study. The Information sheet will also be available on the 'research' section of the clinic website - all women are routinely directed to this page before attending clinic.
Approach by research staff: Following registration, all patients are taken for an ultrasound scan by a clinical support worker to confirm gestation. Following this, patients move to a waiting area until they can be seen for their assessment. While they are waiting, the clinic coordinator will ask the patient if they are happy to be approached by the researcher to discuss the study further. If they are happy to discuss further, the researcher will then approach and discuss the study in a private room.
Consent: If patients are happy to participate in the study, the researcher will then obtain written informed consent prior to their bloods being taken by clinic staff if bloods required for routine care, if no routine bloods are required, the researcher will obtain the blood sample. Participants will be asked if they are planning to use a hormonal form of contraception following their abortion - if yes, they would be asked to wait until they have had their second blood sample taken to commence or not taken forward into the study.
First blood test: This will be obtained on the day of clinic attendance and ultrasound scan. Blood samples (less than 20 ml) will be obtained and taken to the NHS Lothian laboratory at the Royal Infirmary of Edinburgh and for ClotPro thromboelastography point of care testing.
Second blood test: An appointment will be made to see the patient in Chalmers Centre or at their home to obtain a further blood sample to compare to the initial test. This will take place 10-14 days following mifepristone administration. For the repeat sample we will conduct a COVID-19 risk assessment and only invite them for return visit/home visit if:
- The participant has confirmed they and close contacts are well and without suspicion of COVID-19.
- The participant agrees to a home visit.
- The research staff undertaking the home visit should be well and have had no known contact with a COVID-19 positive individual for the past 14 days.
If they are having an intrauterine contraceptive, implant or injection, the second blood sample can be taken when they come into clinic for this, to minimise the number of visits.
Comparison group: A comparison group, Group 4 (10 participants), who are healthy volunteers, recruited from sexual and reproductive health clinics at Chalmers Centre, will be asked to provide a single blood test for ClotPro and lab tests, and urine pregnancy test hCG to act as a nonpregnant comparison. These participants must not be using hormonal contraception and must not be pregnant. This group will be approached by clinicians working in the SRH clinics and the researcher will be on hand to obtain consent and then draw blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Gestation less than 10 weeks | – | Diagnostic Test: Thromboelastometry, Diagnostic Test: Clotting Studies, Diagnostic Test: Full Blood Count, Diagnostic Test: Quantitative hCGBlood tests and urine sample at baseline and 10-14 days after mifepristone administration |
| Group 2: Gestation 10-14 weeks | – | Diagnostic Test: Thromboelastometry, Diagnostic Test: Clotting Studies, Diagnostic Test: Full Blood Count, Diagnostic Test: Quantitative hCGBlood tests and urine sample at baseline and 10-14 days after mifepristone administration |
| Group 3: Gestation 14-20 weeks | – | Diagnostic Test: Thromboelastometry, Diagnostic Test: Clotting Studies, Diagnostic Test: Full Blood Count, Diagnostic Test: Quantitative hCGBlood tests and urine sample at baseline and 10-14 days after mifepristone administration |
| Group 4: Non-pregnant controls | – | Diagnostic Test: Thromboelastometry, Diagnostic Test: Clotting Studies, Diagnostic Test: Full Blood Count, Diagnostic Test: Pregnancy TestBlood tests at baseline only. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women seeking medical abortion at various gestations and non-pregnant comparator group.
Key inclusion criteria (16 listed)
- Pregnant and seeking abortion
- Gestation of pregnancy less than 10 weeks
- Healthy, no medical conditions
- Pregnant and seeking abortion
- Gestation of pregnancy between 10 and 14 weeks
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThromboelastometryPoint of Care Test for clotting parameters (ClotPro device) | Diagnostic test | Group 1: Gestation less than 10 weeks, Group 2: Gestation 10-14 weeks, Group 3: Gestation 14-20 weeks, Group 4: Non-pregnant controls |
| Clotting StudiesStandard laboratory tests for clotting: * International normalised ratio (INR) * Prothrombin time (PT) * adjusted partial thromboplastin time (aPTT) * fibrinogen | Diagnostic test | Group 1: Gestation less than 10 weeks, Group 2: Gestation 10-14 weeks, Group 3: Gestation 14-20 weeks, Group 4: Non-pregnant controls |
| Full Blood CountFor platelet count | Diagnostic test | Group 1: Gestation less than 10 weeks, Group 2: Gestation 10-14 weeks, Group 3: Gestation 14-20 weeks, Group 4: Non-pregnant controls |
| Quantitative hCGSerum human chorionic gonadotrophin | Diagnostic test | Group 1: Gestation less than 10 weeks, Group 2: Gestation 10-14 weeks, Group 3: Gestation 14-20 weeks |
| Pregnancy TestPoint of care urinary pregnancy test | Diagnostic test | Group 4: Non-pregnant controls |
Primary outcome
Clotting Time in Seconds
Time frame: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Clot Formation Time in Seconds
Time frame: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Maximal Amplitude in millimeters
Time frame: 10-14 days
On clotting curve as measured using ClotPro device between baseline and follow up for Groups 1-3.
Maximum Lysis of clot in percentage
Time frame: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Clot Lysis index in percentage
Time frame: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Lysis time in seconds
Time frame: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
13 secondary outcomes
Prothrombin Time in seconds
Time frame: 10-14 days
Activated Partial Thromboplastin Time in seconds
Time frame: 10-14 days
International Normalised Ratio (INR)
Time frame: 10-14 days
Fibrinogen in grams per litre
Time frame: 10-14 days
Platelet count (x10^9 per litre)
Time frame: 10-14 days
Thromboelastography parameters (comparison with non-pregnant group)
Time frame: 10-14 days
Serum hCG in units per litre
Time frame: 10-14 days
Lysis time in seconds
Time frame: 10-14 days
Clot Lysis index in percentage
Time frame: 10-14 days
Maximum Lysis of clot in percentage
Time frame: 10-14 days
Maximal Amplitude in millimeters
Time frame: 10-14 days
Clot Formation Time in Seconds
Time frame: 10-14 days
Clotting Time in Seconds
Time frame: 10-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Reynolds-Wright, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion Early and Abortion, Complete, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clotting Time in Seconds (time frame: 10-14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022; AzTrials last refreshed its copy on 1 Nov 2026.