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Study on Prednisolone for Women with Unexplained Recurrent Miscarriages

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The PREMI trial is focused on studying the condition known as unexplained recurrent miscarriages, which affects some women during early pregnancy. This condition is characterized by experiencing multiple miscarriages without a known cause. The trial aims to explore the effects of a medication called prednisolone, which is a type of steroid, in comparison to a placebo. Prednisolone is taken in tablet form and is being investigated to see if it can help improve the chances of a successful pregnancy and live birth for women who have experienced this condition.

The purpose of the study is to assess whether taking prednisolone during early pregnancy can increase the live birth rate among women with unexplained recurrent miscarriages. Participants in the study will be randomly assigned to receive either prednisolone or a placebo. The study will follow the participants throughout their pregnancy to monitor the outcomes and gather data on the effectiveness of the treatment.

This trial is designed to provide valuable insights into whether prednisolone can be a beneficial treatment option for women facing unexplained recurrent miscarriages. The study will continue until all participants have completed their final visits, and all necessary data has been collected. The results of this research could potentially lead to new treatment approaches for improving pregnancy outcomes in affected women.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age (18-39 years) and history of two or more miscarriages without an identified cause.

    Participation begins after these criteria are met.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information.

    This assessment ensures that there are no underlying conditions that could affect participation.

  3. Step 3

    Medication administration

    Participants receive either prednisolone or a placebo. Prednisolone is administered orally.

    The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring occurs to assess the effects of the medication.

    Follow-up visits are scheduled to track progress and gather data on outcomes, such as the live birth rate.

  5. Step 5

    Completion of participation

    Participation concludes when the last study visit is completed and all necessary data is collected.

    The study is expected to end by July 1, 2027, unless advised otherwise by the Data Safety Monitoring Board.

Who can join the trial?

3 criteria

  • Must be a woman aged between 18 and 39 years old.
  • Must have experienced two or more miscarriages. **Mola** and **ectopic pregnancies** are not counted. Mola refers to a rare condition where a tumor forms in the uterus at the beginning of a pregnancy. Ectopic pregnancy is when a pregnancy occurs outside the uterus, usually in a fallopian tube.
  • No underlying cause for the miscarriages was found after medical examination.

Who cannot join the trial?

4 criteria

  • Women who are not experiencing unexplained recurrent miscarriages cannot participate. This means the study is only for women who have had multiple miscarriages without a known cause.
  • Men are not eligible to participate in this study.
  • Participants must be within a specific age range, which is not specified here, but generally means they must be of childbearing age.
  • Individuals who are considered part of a vulnerable population may not be eligible. This term often refers to groups who may need special protection, such as those with limited ability to give consent or those at higher risk of harm.
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Investigated drugs

Prednisolone is a medication used in this trial to help women who have experienced multiple unexplained miscarriages. The trial aims to see if taking prednisolone during early pregnancy can increase the chances of having a successful live birth. Prednisolone is a type of steroid that can help reduce inflammation and is being tested to see if it can improve pregnancy outcomes for these women.

What is already known about the treatment

Prednisolone – Prednisolone is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in women experiencing unexplained recurrent miscarriages. The main therapeutic indication being explored is its ability to improve live birth rates in this group. At the molecular level, prednisolone works by suppressing the immune system and reducing inflammation, which may help in maintaining pregnancy. It is classified as a corticosteroid, a type of medication that mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Unexplained Recurrent Miscarriages – This condition involves experiencing two or more consecutive pregnancy losses before the 20th week of gestation, without an identifiable cause after thorough medical evaluation. The progression of this condition is characterized by repeated pregnancy loss, often occurring at similar stages of pregnancy. Women with this condition may experience normal pregnancies interspersed with miscarriages. The exact cause remains unknown, which can make management challenging. It is a distressing condition that can have significant emotional and psychological impacts on those affected.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503220-76-01Protocol codeLUMC-PREMIEstimated enrolment490 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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