Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

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.

Timeline

Start

2024-01-29

Primary completion

2026-07-29

Completion

2027-07-29

Publications

• Bequet Y, van der Hoorn ML, Eikmans M, Van der Molen R, le Cessie S, van Geloven N, van den Akker-van Marle E, Vermeulen M, van den Berg M, de Bruin JP, Cantineau A, Huppelschoten D, Meuleman T, Mulders A, Al-Nasiry S, Teklenburg G, Verhoeve H, Visser J, van der Zanden M, Goddijn M, Lashley E. Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study). BMJ Open. 2025 Jun 19;15(6):e096545. doi: 10.1136/bmjopen-2024-096545.

Drugs

Indications