Study of Prednisolone Treatment to Improve Live Birth Rates in Women With Unexplained Recurrent Miscarriages

What this Trial Is About

Recurrent miscarriage RM affects about 3% of fertile couples and often has no known cause, limiting treatment options. Researchers are studying how the immune system might contribute to RM and whether prednisolone, a medicine that suppresses the immune system, can improve the chance of a live birth in women with unexplained RM. This randomized controlled trial will compare prednisolone with a placebo in women aged 18 to 39 who have had at least two unexplained miscarriages and are less than 7 weeks pregnant. Participants will be randomly assigned to receive either prednisolone tablets or identical placebo tablets for 8 weeks. The prednisolone dosage is 20 mg daily for 6 weeks, then reduced to 10 mg daily for 1 week, followed by 5 mg daily for 1 week. Alongside this, participants will continue with their usual prenatal care. Some participants will also provide samples for immune cell analysis to understand prednisolones effects. Questionnaires will be completed at randomization and at 3, 6, and 12 months afterward. During the study, women will have contact with a research nurse to monitor pregnancy progress and any side effects. The main measure is the live birth rate within 24 months after eligibility. Secondary outcomes include miscarriage rates, pregnancy complications, safety for mother and child, quality of life, costs, and anxiety or depression levels. Follow-up continues up to 3 months after delivery, totaling 12 months after randomization, to ensure thorough monitoring of outcomes and safety.

Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages