Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages
Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Leiden University Medical Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academisch Ziekenhuis Groningen Amphia Hospital Catharina Ziekenhuis Eindhoven Erasmus Medical Center Haaglanden Medical Centre Isala Maastricht University Medical Center Radboud University Medical Center