Using prednisolone to help women with unexplained recurrent miscarriages
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial
PHASE4 · Leiden University Medical Center · NCT05725512
This study is testing if taking prednisolone can help women who have had multiple unexplained miscarriages have a successful pregnancy.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT05725512 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-39 who have experienced two or more unexplained miscarriages.
Not a fit: Patients over the age of 39 or those with known causes of recurrent miscarriages will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the chances of live births for women with unexplained recurrent miscarriages.
How similar studies have performed: Previous studies have suggested potential benefits of prednisolone in improving live birth rates, but this trial aims to provide more robust evidence in an unselected population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leiden, South Holland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion, Miscarriage, Fertility Disorders, Recurrent pregnancy loss, Recurrent miscarriage, prednisolone