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Clotting Parameters After Medical Abortion

NCT04824118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

  • Abortion Early
  • Abortion, Complete
  • Abortion, Second Trimester
  • Termination of Pregnancy Complicated by Embolism
  • Venous Thromboses
  • Venous Thromboembolism
  • Venous Thromboembolic Disease
  • Clotting Disorder

Interventions

DIAGNOSTIC_TEST

Thromboelastometry

Point of Care Test for clotting parameters (ClotPro device)

DIAGNOSTIC_TEST

Clotting Studies

Standard laboratory tests for clotting: * International normalised ratio (INR) * Prothrombin time (PT) * adjusted partial thromboplastin time (aPTT) * fibrinogen

DIAGNOSTIC_TEST

Full Blood Count

For platelet count

DIAGNOSTIC_TEST

Quantitative hCG

Serum human chorionic gonadotrophin

DIAGNOSTIC_TEST

Pregnancy Test

Point of care urinary pregnancy test

Sponsors & Collaborators

  • University of Edinburgh

    collaborator OTHER

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • John J Reynolds-Wright, MBChB · University of Edinburgh

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2021-08-12
Completion
2021-08-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824118 on ClinicalTrials.gov