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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55412

Enrollment

200

Registered

2012-11-26

Start date

2013-04-24

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

deep vein thrombosis

Interventions

Treatment with LMWH in low or intermediate dose.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Pregnancy confirmed by urinary pregnancy test, gestational age

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Recurrence of VTE.	—

Secondary

Measure	Time frame
Safety (especially bleeding).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)