Effectiveness of Dalteparin Therapy as Intervention in recurrent pregnancy loss - EHTIG II

• Conditions: Pregnant women with a history of recurrent pregnancy loss, defined as:-2 or more early (< 12 weeks of gestation) pregnancy losses or-1 or more late (> 12 weeks of gestation) pregnancy loss; MedDRA version: 8.1Level: LLTClassification code 10036562Term: Pregnancy in habitual aborter

• Registration Number: EUCTR2006-001984-53-DE
• Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-19
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 486

Inclusion Criteria

Patients must meet ALL of the following criteria:

Single pregnancy, 5th to 8th week of gestation
Documented foetal heart activity in US
History of recurrent pregnancy loss, defined as:
-2 or more early (< 12 weeks of gestation) pregnancy losses or
-1 or more late (> 12 weeks of gestation) pregnancy loss
Age > 18 years
Written informed consent of the patient

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

Patients will be excluded for ANY ONE of the following reasons:
Previous pregnancy losses caused by foetal structural or chromosomal anomalies
Uterine anomalies
Maternal infection which caused previous pregnancy loss
Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis)
Acute thromboembolic event (need of heparin therapy)
Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin)
Antiphospholipid antibody syndrome
Diabetes mellitus
Ongoing nicotine or drug or alcohol abuse
HIV positive
Expected low compliance (e.g. by travel distance to trial site)
Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
Injuries or surgeries of CNS, eyes or ear during the last 8 weeks prior to randomisation
Active clinical significant bleeding (e.g. gastrointestinal, intracranial, intraocular) during the last 3 months prior to randomisation
Diseases associated with enhanced predisposition of bleeding (e.g. hemorrhagic diathesis, deficiency of coagulation factors, severe affection of liver, kidney or pancreas, severe thrombocytopenia)
Diseases caused by lesions of the vascular system (e.g. gastric, peptic or intestinal ulcer, hypertension (RR diast. > 105 mmHg, hemorrhagic apoplectic insult (3 month prior to randomisation), aneurysm of brain artery, retinopathies, bleeding of vitreous body, endocarditis lenta or septica)
Renal and urethra calculi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can the rate of pregnancy losses before the 24th week of gestation be reduced by dalteparin treatment? <br>;Secondary Objective: Can the rate of live births be increased by dalteparin treatment?<br>Can the rate of late pregnancy complications (preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae) be reduced by dalteparin treatment?<br>Description and comparison of the rate of foetal structural anomalies<br>Description and comparison of symptomatic venous thrombembolic events during the pregnancy<br>Description of the side effects of dalteparin (e.g. thrombocytopenia, osteoporosis, haemorrhage)<br><br><br><br><br><br><br>;Primary end point(s): The primary end point is ongoing intact pregnancy at 24 weeks of gestation.