previous preeclampsia MedDRA version: 9.1 Level: PT Classification code 10036485 Term: Pre-eclampsia
Conditions
Interventions
Trade Name: CLEXANE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Enoxaparin
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: .4-
Trade Name: CA
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pregnant women before 8 weeks with previous preeclampsia untreated with anticoagulant and antiaggregant Women in preconceptional period with previous preeclampsia untreated with anticoagulant and antiaggregant 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: Normal pregnancy after a pregnancy complicated by preeclamsia Acquired or inherited thrombophilia Secondary chronic Hypertension ASA allergy Missing consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this prospective randomized trial is to validate if the anticoagulant action of LMWH plus the antiaggregant action of low dose aspirin can improve the pregnancy outcome in women with previous severe preeclamsia, low birth weight and Intra uterine growth restriction.;Secondary Objective: nd;Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed