Measuring the Changes in Clotting Parameters Before and After Medical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Lysis time in seconds
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •Healthy, no medical conditions
- •Pregnant and seeking abortion
- •Gestation of pregnancy between 14 to 20 weeks
- •Healthy, no medical conditions
- •Non pregnant
- •Healthy, no medical conditions
- •Able to speak English independently
排除标准
- •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.
- •Using hormonal contraception at baseline visit
结局指标
主要结局
Lysis time in seconds
时间窗: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Clotting Time in Seconds
时间窗: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Maximal Amplitude in millimeters
时间窗: 10-14 days
On clotting curve as measured using ClotPro device between baseline and follow up for Groups 1-3.
Clot Lysis index in percentage
时间窗: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Clot Formation Time in Seconds
时间窗: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
Maximum Lysis of clot in percentage
时间窗: 10-14 days
As measured using ClotPro device between baseline and follow up for Groups 1-3.
次要结局
- Prothrombin Time in seconds(10-14 days)
- Thromboelastography parameters (comparison with non-pregnant group)(10-14 days)
- Maximal Amplitude in millimeters(10-14 days)
- Activated Partial Thromboplastin Time in seconds(10-14 days)
- International Normalised Ratio (INR)(10-14 days)
- Clot Formation Time in Seconds(10-14 days)
- Platelet count (x10^9 per litre)(10-14 days)
- Serum hCG in units per litre(10-14 days)
- Lysis time in seconds(10-14 days)
- Clot Lysis index in percentage(10-14 days)
- Maximum Lysis of clot in percentage(10-14 days)
- Fibrinogen in grams per litre(10-14 days)
- Clotting Time in Seconds(10-14 days)