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: 6.1 Level: SOC Classification code 10036585
Conditions
Interventions
Trade Name: CLEXANE*6SIR 4000UI/0,4ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Enoxaparin
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration
Sponsors
OSPEDALE MAGGIORE DI MILANO IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1 previus obstetrical complication associated with an antomical, chromosomical, endocrine, traumatic or infectius cause; 2 History of venous
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 . | — |
Countries
Italy
Outcome results
None listed