Highlow study: prevention of recurrent deep vein thrombosis and lung embolism in pregnant women

INTERVENTION: Trade Name: Fraxodi Product Name: Fraxodi Product Code: na Pharmaceutical Form: Solution for injection INN or Proposed INN: NADROPARIN CAS Number: 37270‐89‐6 Current Sponsor code: nadroparin Other descriptive name: na Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 19000‐ Trade Name: Fraxodi Product Name: Fraxodi Product Code: nadroparin Pharmaceutical Form: Solution for injection INN or Proposed INN: NADROPARIN CAS Number: 37270‐89‐6 Current Sponsor code: nadroparin Other descriptive name: na Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 19000‐ CONDITION: deep vein thrombosis pulmonary embolism ; MedDRA version: 14.1 Level: LLT Classification code 10066529 Term: Deep vein thrombosis recurrent System Organ Class: 100000004866 ; MedDRA version: 14.1 Level: LLT Classification code 10066738 Term: Recurrent pulmonary embolism System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy and safety of intermediate dose LMWH versus fixed low dose LMWH in pregnant women with a history of previous VTE. Primary end point(s): ‐Recurrent VTE during pregnancy or in the 1st 6 weeks after delivery; ‐Adverse events Secondary Objective: n.a. Timepoint(s) of evaluation of this end point: Continuously from start of prophylaxis (pregnancy week 4‐14) until week 6 after delivery SECONDARY OUTCOME: Secondary end point(s): n.a. Timepoint(s) of evaluation of this end point: n.a. 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