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.

Conditions

• Recurrent Miscarriage
• Recurrent Pregnancy Loss
• Habitual Abortion
• Miscarriage
• Fertility Disorders

Interventions

DRUG

Prednisolone

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

DRUG

Placebo

Placebo identical to prednisolone tablets

Sponsors & Collaborators

• Amsterdam University Medical Center

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Academisch Ziekenhuis Groningen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Isala

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Haaglanden Medical Centre

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Jeroen Bosch Ziekenhuis

  collaborator OTHER

• Onze Lieve Vrouwe Gasthuis

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-29

Primary Completion

2026-07-29

Completion

2027-07-29

Countries

• Netherlands

Study Locations