Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

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.

NCT Number	NCT05725512
Lead Sponsor	Leiden University Medical Center Collaborators: Amsterdam University Medical Center, Erasmus Medical Center, Academisch Ziekenhuis Groningen, Maastricht University Medical Center, Isala, Catharina Ziekenhuis Eindhoven, Haaglanden Medical Centre, Amphia Hospital, Radboud University Medical Center, Jeroen Bosch Ziekenhuis, Onze Lieve Vrouwe Gasthuis
Conditions	Recurrent Miscarriage, Recurrent Pregnancy Loss, Habitual Abortion, Miscarriage, Fertility Disorders
Enrollment	490 participants
Start Date	2024-01-29
Primary Completion	2026-07-29 (estimated)
Study Completion	2027-07-29 (estimated)
Updated on ClinicalTrials.gov	2024-05-24