Highlow study: Low-molecular-weight heparin to prevent recurrent VTE in pregnancy: a randomized controlled trial of two doses

Phase 4

Completed

• Conditions: deep vein thrombosis; pulmonary embolism; 10010273; 10014523

• Registration Number: NL-OMON55412
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- Age >= 18 years
- Pregnancy confirmed by urinary pregnancy test, gestational age < 14 weeks
since first day of last menstrual period
- Previous objectively confirmed VTE, either unprovoked, in the presence of use
of oral contraceptives or estrogen/progestagen use, or related to pregnancy or
the postpartum period, or minor risk factors (e.g. long distance travel, minor
trauma)

Exclusion Criteria

- Previous VTE related to a major provoking risk factor (e.g. surgery, major
trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole
risk factor
- Indication for treatment with therapeutic dose anticoagulant therapy (e.g.
treatment of acute VTE; permanent use of therapeutic anticoagulants outside of
pregnancy)
- Inability to provide informed consent
- Any contraindication listed in the local labelling of LMWH.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Recurrence of VTE.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety (especially bleeding).</p><br>