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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004881-15-FR
Enrollment
Unknown
Registered
2007-07-23
Start date
2007-08-08
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia complicating preeclampsia MedDRA version: 9.1 Level: LLT Classification code 10043554 Term: Thrombocytopenia

Interventions

Trade Name: METHYL PREDNISOLONE Product Name: METHYLPREDNISOLONE MERCK 20 MG Pharmaceutical Form: Powder for injection* Pharmaceutical form of the placebo: Solution for injection Route of administrat

Sponsors

CHU DE POITIERS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All pregnancies complicated by preeclampsia (defined according to ISHP criteria) with a fall of platelets =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women with maternal or foetal complications imposing an immediate parturition· Women with a platelet number 38°C at 2 occasions separated by 3h)· Women with diabetes, hypokalemia, or treated by medicines exposing to cardiac arrhythmia

Design outcomes

Primary

MeasureTime frame
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 - To evaluate maternal and foetal tolerance of methylprednisolone;Primary end point(s): platelet count > 50 x 109/L at H36

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026