Highlow study: Prevention of recurrent deep vein thrombosis and lung embolism in pregnant women

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001505-24-NL

Enrollment

790

Registered

2012-11-26

Start date

2013-02-25

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

deep vein thrombosis pulmonary embolism MedDRA version: 21.1 Level: LLT Classification code 10066529 Term: Deep vein thrombosis recurrent System Organ Class: 100000004866 MedDRA version: 21.1 Level: LLT Classification code 10066738 Term: Recurrent pulmonary embolism System Organ Class: 100000004855

Interventions

Trade Name: Fraxiparine Product Name: Fraxiparine Product Code: na Pharmaceutical Form: Solution for injection INN or Proposed INN: NADROPARIN CAS Number: 37270-89-6 Current Sponsor code: nadroparin O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Age = 18 years -Pregnancy confirmed by urinary pregnancy test, gestational age =65 years) no F.1.3.1 Number of subjects for this age range

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
Main Objective: To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous VTE.;Secondary Objective: n.a.;Primary end point(s): -Recurrent VTE during pregnancy or in the 1st 6 weeks after delivery -Adverse events;Timepoint(s) of evaluation of this end point: Continuously from start of prophylaxis (pregnancy week 4-14) until week 6 after delivery	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous VTE.;Secondary Objective: n.a.;Primary end point(s): -Recurrent VTE during pregnancy or in the 1st 6 weeks after delivery -Adverse events;Timepoint(s) of evaluation of this end point: Continuously from start of prophylaxis (pregnancy week 4-14) until week 6 after delivery

—

Secondary

Measure	Time frame
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Belgium, Denmark, Ireland, Netherlands, Spain

Contacts

Public ContactProject leader

AMC

S.Middeldorp@amc.uva.nl+31205669111na

Outcome results

None listed

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