Using prednisolone to help women with unexplained recurrent miscarriages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effect of prednisolone, an immunosuppressive medication, on the live birth rate in women experiencing unexplained recurrent miscarriages. Participants will be randomly assigned to receive either prednisolone or a placebo for 8 weeks, starting before 7 weeks of gestation. The study aims to assess not only the effectiveness of the treatment but also its safety, tolerability, and cost-effectiveness. Participants will complete questionnaires and have regular contact with a research nurse to monitor their pregnancy progress.

Why it matters

Who can join: the full rules

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Unexplained recurrent pregnancy loss: defined as the loss of ≥2 pregnancies, without any known cause for RM (parental chromosomal abnormalities, uterine anomalies, acquired or hereditary thrombophilia, endocrine diseases (such as hypothyroidism or diabetes)).
* The miscarriages include:

  * all consecutive or non-consecutive pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology
  * non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive urine or serum hCG Ectopic and molar pregnancies are not included
* Age 18 - 39 years at randomization (likelihood of miscarriages due to chromosomal aberrations is higher when age \> 39 years. Such miscarriages are unlikely to be pre-vented by prednisolone therapy)
* Conception confirmed by urinary pregnancy test, with estimated gestational age ≤ 7weeks
* Willing and able to give informed consent in English or Dutch (IC)

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Any of the following diagnosis for the recurrent miscarriages

  * Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin anti-bodies and/or beta-2 glycoprotein \[IgG or IgM)
  * Congenital uterine abnormalities (as assessed by 2D or 3d ultrasound, hys-terosonography, hysterosalpingogram or hysteroscopy)
  * Abnormal parental karyotype
* Instable or exacerbation of auto-immune diseases such as diabetes, thyroid disease, inflammatory bowel diseases or SLE
* Inability to conceive within 1 year of recruitment
* Current treatment with systemic prednisolone or other immune suppressive medication (for any indication)
* Previous enrolment in the PREMI trial
* Enrolment in any other trial that studies the effectiveness of an intervention on RM
* Contraindications to prednisolone use:

  * Known allergy for prednisolone
  * Acute bacterial infection or parasite infection
  * Active COVID infection
  * Systemic sclerosis
  * Ulcus ventriculi or ulcus duodeni in medical history
  * Obesity with BMI \>40
* Some drugs are known to interact with Prednisolone, and thus women on the following drugs are not eligible to take part in the PREMI trial:

  * Enzyme inducers, such as carbamazepine, fenobarbital, fenytoïne and ri-fampicine
  * CYP3A inhibitors, such as Cobicistat or Ritonavir
  * Cyclosporine
  * Digoxin
  * Vaccination (with inactivated virus or bacteria) during prednisolone use is possibly less effective

Where it's running

• Leiden University Medical Center
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Eileen Lashley, PhD
• Email: e.e.l.o.lashley@lumc.nl
• Phone: 0031-715263362

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.