Actively Recruiting

Phase 4
Age: 18Years - 40Years
FEMALE
ID05725512

Prednisolone Administration in Patients With Unexplained Recurrent Miscarriages PREMI Trial

Led by Leiden University Medical Center · Updated on 2024-05-24

490

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

A

Amsterdam University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Recurrent miscarriage (RM) affects about 3% of fertile couples and often has no known cause, limiting treatment options. Researchers are studying how the immune system might contribute to RM and whether prednisolone, a medicine that suppresses the immune system, can improve the chance of a live birth in women with unexplained RM. This randomized controlled trial will compare prednisolone with a placebo in women aged 18 to 39 who have had at least two unexplained miscarriages and are less than 7 weeks pregnant. Participants will be randomly assigned to receive either prednisolone tablets or identical placebo tablets for 8 weeks. The prednisolone dosage is 20 mg daily for 6 weeks, then reduced to 10 mg daily for 1 week, followed by 5 mg daily for 1 week. Alongside this, participants will continue with their usual prenatal care. Some participants will also provide samples for immune cell analysis to understand prednisolone's effects. Questionnaires will be completed at randomization and at 3, 6, and 12 months afterward. During the study, women will have contact with a research nurse to monitor pregnancy progress and any side effects. The main measure is the live birth rate within 24 months after eligibility. Secondary outcomes include miscarriage rates, pregnancy complications, safety for mother and child, quality of life, costs, and anxiety or depression levels. Follow-up continues up to 3 months after delivery, totaling 12 months after randomization, to ensure thorough monitoring of outcomes and safety.

CONDITIONS

Brief Title

Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 39 years at randomization
  • Unexplained recurrent pregnancy loss defined as two or more pregnancy losses without known cause
  • Pregnancy losses include all miscarriages before 24 weeks confirmed by ultrasound or histology, plus biochemical pregnancies
  • Current pregnancy confirmed by positive pregnancy test with gestational age less than or equal to 7 weeks
  • Able and willing to give informed consent in English or Dutch
Not Eligible

You will not qualify if you...

  • Diagnosed causes for recurrent miscarriage such as antiphospholipid syndrome, congenital uterine abnormalities, or abnormal parental karyotype
  • Unstable or worsening autoimmune diseases like diabetes, thyroid disease, inflammatory bowel disease, or lupus
  • Inability to conceive within one year of recruitment
  • Current treatment with systemic prednisolone or other immune suppressive medication
  • Prior participation in the PREMI trial or enrollment in other RM intervention trials
  • Known allergy to prednisolone
  • Presence of acute bacterial or parasite infections, active COVID infection, systemic sclerosis
  • History of stomach or duodenal ulcers
  • Obesity with BMI over 40
  • Use of certain medications that interact with prednisolone such as enzyme inducers, CYP3A inhibitors, cyclosporine, digoxin
  • Vaccination with inactivated virus or bacteria during prednisolone use may reduce effectiveness and is excluded

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants take prednisolone tablets (20 mg daily for 6 weeks, 10 mg daily for 1 week, 5 mg daily for 1 week) or identical placebo tablets for 8 weeks during early pregnancy.

Prenatal visits according to standard care with their own treating physician

Follow-up

Duration - Up to 24 months after eligibility

Participants complete questionnaires at randomization, and 3, 6, and 12 months after randomization to assess pregnancy outcomes, side effects, and quality of life. Additional monitoring includes pregnancy complications and birth outcomes up to 24 months after eligibility.

Questionnaires at 4 time points and prenatal visits as part of routine care

Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 233ZA

Actively Recruiting

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Research Team

E

Eileen Lashley, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study).

Yentl Béquet, Marie-Louise van der Hoorn, Michael Eikmans...

https://pubmed.ncbi.nlm.nih.gov/40537239