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An observational study to assess risk factors leading to development of venous thromboembolism in pregnant women

Risk aSsessment and management of Vte in women at risk of thromboEmbolism during pregnancy and puerperium - SAVE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/05/005785
Enrollment
3300
Registered
2015-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremity Health Condition 2: null- Venous Thromboembolism

Interventions

None listed

Sponsors

Sanofi India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women with objectively confirmed pregnancy coming for: a) First prenatal consultation or any consultation occurring during pregnancy b) Intercurrent medical condition with or without need for hospitalisation c) Labour/ delivery 3. Women having signed informed consent at enrolment in the study.

Exclusion criteria

Exclusion criteria: 1. Women who have experienced VTE (DVT and/or PE) in the 4 months before inclusion in the trial 2. Women already receiving antithrombotic therapy for medical reason: previous VTE, atrial fibrillation, mechanical prosthetic heart valves 3. Refusal or inability to give informed consent to participate in the study. 4. Current participation in any other clinical trial.

Design outcomes

Primary

MeasureTime frame
Rate of women at risk of VTE during pregnancy and post-partum period.Timepoint: Q3 2016

Secondary

MeasureTime frame
"The proportion of at risk women receiving effective type of VTE Prophylaxis according to ACCP and/or RCOG guidelines. - The factors driving VTE prophylaxis decisions - The overall rate of patients receiving mechanical vs. pharmacological prophylaxis - The proportion of physicians following international guidelines - The association between physicianâ??s knowledge of the guidelines and their attitude regarding VTE Prophylaxis " Timepoint: Q3 2016

Countries

Azerbaijan, Bangladesh, Egypt, Georgia, Ghana, India, Iraq, Jordan, Kenya, Lebanon, Morocco, Nigeria, Pakistan, Russian Federation, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Uzbekistan

Contacts

Public ContactMr Ajit Walekar

Sanofi India Limited

Ajit.Walekar@sanofi.com02230707824

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026