Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial
Leiden University Medical Center
490 participants
Jan 29, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
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
Placebo identical to prednisolone tablets
Locations(1)
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NCT05725512