A Randomised controlled tiral to evaluate the efficacy of low molecular-weight heparin on pregnancy outcome of women with previus pregnancy complication - Heparin for prevention of pregnancy complicatio

Phase 1

• Conditions: To asses wether the treatment with LMWH in Women with previus pregnancy complications and no evidence of anatomical, endocrine, Cromosmal or immunological abnormality result in a 40 reduction in the rate of expected complication estimatedv as 40 .; MedDRA version: 6.1Level: SOCClassification code 10036585

• Registration Number: EUCTR2006-004205-26-IT
• Lead Sponsor: OSPEDALE MAGGIORE DI MILANO IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-10
• Study Completion: 2011-01-25
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 266

Inclusion Criteria

1 History of at least 1 a pre-eclampsia blood pressure 140/90 mmHg on two or more occasions occorring 20 weeks of gestation, together with proteinuria 0,3g/24h or 3 dipstick testing or oclampsia defined as the presence of new onest seizures in a preclamptic patients 22 b HELLP Hemolysis, helevated liver enzymes and low platelet syndrome the following laboratory findings in combination 1 hemolysis lactic dehidrogenase 600IU/l or serum bilirubin 1.2mg/dl or presence of schistocytes in the peripheral blood ; 2 increased serum AST concentration 70UL/l ; 3 Thrombocytopenia PLT below 100,000/mm3 c placental abruption d fetal growth restriction defined as 1 birthwight below the 10th percentile for gestational ege. And 2 a percentile reduction of the abdominal circumference 40 by ultrasaund US 23,24 ; e spontaneus pregnancy loss 15th gestational week. f At last 2 early spontaneus pregnancy losses below 15th gestational week ; 2 previus obstetrical complication not associatede with an antomical, chromosomical, endocrine, traumatic or infectius cause; 3 Present at less than 12 weeks gestation with a postitive pregnency test and confirmatory US 4 give written 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

1 previus obstetrical complication associated with an antomical, chromosomical, endocrine, traumatic or infectius cause; 2 History of venous

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To asses wether the treatment with LMWH in Women with previus pregnancy complications and no evidence of anatomical, endocrine, Cromosmal or immunological abnormality result in a 40 reduction in the rate of expected complication estimatedv as 40 .;Secondary Objective: Data will also be collected on the immediate tollerance and safety of LMWH THerapy in Pregnancy.;Primary end point(s): To asses wether the treatment with LMWH in Women with previus pregnancy complications and no evidence of anatomical, endocrine, Cromosmal or immunological abnormality result in a 40 reduction in the rate of expected complication estimatedv as 40 .