Efficiency and tolerance study of methylprednisolone on the fall of platelets complicating preeclampsia - Multicentric, prospective, controlled, randomised, double blind, versus placebo, with individual benefit biomedical trial - PRETTY

Conditions: Thrombocytopenia complicating preeclampsia
MedDRA version: 9.1Level: LLTClassification code 10043554Term: Thrombocytopenia

Registration Number: EUCTR2006-004881-15-FR

Lead Sponsor: CHU DE POITIERS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

All pregnancies complicated by preeclampsia (defined according to ISHP criteria) with a fall of platelets < 150 x 109/L
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

Women with maternal or foetal complications imposing an immediate parturition·
Women with a platelet number < 50 x 109/L before inclusion·
Women with overt infection (fever > 38°C at 2 occasions separated by 3h)·
Women with diabetes, hypokalemia, or treated by medicines exposing to cardiac arrhythmia

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate efficiency of early treatment with methylprednisolone in order to reduce the fall of platelets during preeclampsia complicated of thrombocytopenia;Secondary Objective: - To assess the possibility of performing a regional anesthesia for delivery <br> - To evaluate maternal and foetal tolerance of methylprednisolone;Primary end point(s): platelet count > 50 x 109/L at H36

Secondary Outcome Measures