Actively Recruiting
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
Led by Leiden University Medical Center · Updated on 2024-05-24
490
Participants Needed
1
Research Sites
182 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 miscarriages (RM) affects 3% of all fertile couples, but remains unexplained in most cases, limiting therapeutic options. Possibly the maternal immune system plays a role in recurrent miscarriage. Prednisolone suppresses the immune system and might enable development of normal pregnancy. In this randomized controlled clinical trial the investigators will study the effect of prednisolone on the live birth rate in patients with RM. Secondary, the tolerability and safety for mother and child and the cost-effectiveness is investigated. In the study one group of pregnant women with RM and gestational age \<7 weeks will receive prednisolone, the other group will receive a placebo. Total use of the medicine during this study is 8 weeks, further care during the study is routinely antenatal care. Subjects will be asked to fill in 4 short questionnaires and will have contact with a research nurse at different time points to gain information on the course of the pregnancy and possible side effects. Results of the study will be implemented in (inter) national guidelines, to effect everyday practice.
CONDITIONS
Official Title
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 39 years at randomization
- Experienced two or more unexplained pregnancy losses before 24 weeks gestation confirmed by ultrasound or histology
- Includes non-visualized pregnancies confirmed by positive pregnancy tests
- Current pregnancy confirmed by urinary pregnancy test with gestational age less than or equal to 7 weeks
- Able and willing to provide informed consent in English or Dutch
You will not qualify if you...
- Diagnosis of antiphospholipid syndrome, congenital uterine abnormalities, or abnormal parental karyotype
- Unstable or worsening autoimmune diseases such as diabetes, thyroid disease, inflammatory bowel disease, or systemic lupus erythematosus
- Unable to conceive within one year of recruitment
- Current treatment with systemic prednisolone or other immune-suppressing drugs
- Previous participation in the PREMI trial or enrollment in another RM intervention trial
- Contraindications to prednisolone including allergy, acute bacterial or parasite infection, active COVID infection, systemic sclerosis, history of stomach or duodenal ulcers, or obesity with BMI over 40
- Use of certain interacting drugs including enzyme inducers, CYP3A inhibitors, cyclosporine, digoxin
- Receiving vaccinations during prednisolone use due to possible reduced effectiveness
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 233ZA
Actively Recruiting
Research Team
E
Eileen Lashley, PhD
CONTACT
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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