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PREMI trial
EU CTIS ID: 2023-503220-76-01
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-39
- Two or more miscarriages (mola and ectopic pregnancies excluded)
- No underlying cause was found for miscarriages after examination
You likely can't join if
- 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)
See the full eligibility criteria
- Age 18-39
- Two or more miscarriages (mola and ectopic pregnancies excluded)
- No underlying cause was found for miscarriages after examination
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.