Low molecular weight heparin (Fragmin) in pregnant women with a history of uteroplacental insufficiency and thrombophilia, a randomized trial - FRUIT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005850-30-AT

Enrollment

262

Registered

2006-01-23

Start date

2006-02-27

Completion date

Unknown

Last updated

2015-10-26

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

Conditions

Women with a history of pre-eclampsia and babies small for gestational age

Interventions

Trade Name: Fragmin Product Name: Dalteparin Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women wit a history of pre-eclampsia and babies small for gestational age before 34 weeks of gestation Thrombophilia Age >18 years Informed consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: AT-deficiency, diabetes mellitus, known malignancy, gastroduodenal-ulcer, severe renal or hepatic insufficiency, thromboembolism in histoty, hemorrhagic diathesis, ITP

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether Dalteparin improves the outcome of pregnancy;Secondary Objective: ;Primary end point(s): Recurrence of pre-eclampsia and small for gestational age babies	—

Countries

Austria

Outcome results

None listed

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