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

Phase 1

• Conditions: deep vein thrombosispulmonary embolism; MedDRA version: 16.1Level: LLTClassification code 10066529Term: Deep vein thrombosis recurrentSystem Organ Class: 100000004866; MedDRA version: 16.1Level: LLTClassification code 10066738Term: Recurrent pulmonary embolismSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001505-24-IE
• Lead Sponsor: The Rotunda Maternity Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-14
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 850

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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 850
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified