PREMI trial
Phase 1
Recruiting
- Conditions
- nexplained recurrent miscarriagesMedDRA version: 21.1Level: LLTClassification code: 10038104Term: Recurrent abortion Class: 10036585Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2023-503220-76-01
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 490
Inclusion Criteria
Age 18-39, Two or more miscarriages (mola and ectopic pregnancies excluded), No underlying cause was found for miscarriages after examination
Exclusion Criteria
Diabetes with medication, Previous enrollment/ participation in PREMI trial, Contraindication for the use of glucocorticosteroids, Use of medication that interferes with prednisolone (see protocol for list), Instable or exacerbation of auto-immune disease, Use of immune suppressing medication (for any reason), Participation or enrollment in other interventional trial for recurrent miscarriages
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary aim of the PREMI trial is to assess the effect of prednisolone administration during early pregnancy in women with unexplained recurrent miscarriages in comparison to the use of a placebo, specifically focusing on the live birth rate as the primary outcome measure.;Secondary Objective: Ongoing pregancy rate, Miscarriage rate, Evaluate side-effects and adverse events (congenital birth defects, low birth-weight, maternal side-effects etc.);Primary end point(s): Last study subject has completed last visit and all data is gathered
- Secondary Outcome Measures
Name Time Method Secondary end point(s):DSMB advises to stop trial (for feasibility, slow inclusion rate, safety concerns etc.)