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RECRUITING

NCT05725512

PHASE4

Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

Official title: Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages, PREMI Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

490

Start Date

2024-01-29

Completion Date

2027-07-29

Last Updated

2024-05-24

Healthy Volunteers

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

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Unexplained recurrent pregnancy loss: defined as the loss of ≥2 pregnancies, without any known cause for RM (parental chromosomal abnormalities, uterine anomalies, acquired or hereditary thrombophilia, endocrine diseases (such as hypothyroidism or diabetes)). * The miscarriages include: * all consecutive or non-consecutive pregnancy losses before the 24th week of gestation verified by ultrasonography or uterine curettage and histology * non-visualized pregnancies (including biochemical pregnancy losses and/or resolved and treated pregnancies of unknown location), verified by positive urine or serum hCG Ectopic and molar pregnancies are not included * Age 18 - 39 years at randomization (likelihood of miscarriages due to chromosomal aberrations is higher when age \> 39 years. Such miscarriages are unlikely to be pre-vented by prednisolone therapy) * Conception confirmed by urinary pregnancy test, with estimated gestational age ≤ 7weeks * Willing and able to give informed consent in English or Dutch (IC) Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Any of the following diagnosis for the recurrent miscarriages * Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin anti-bodies and/or beta-2 glycoprotein \[IgG or IgM) * Congenital uterine abnormalities (as assessed by 2D or 3d ultrasound, hys-terosonography, hysterosalpingogram or hysteroscopy) * Abnormal parental karyotype * Instable or exacerbation of auto-immune diseases such as diabetes, thyroid disease, inflammatory bowel diseases or SLE * Inability to conceive within 1 year of recruitment * Current treatment with systemic prednisolone or other immune suppressive medication (for any indication) * Previous enrolment in the PREMI trial * Enrolment in any other trial that studies the effectiveness of an intervention on RM * Contraindications to prednisolone use: * Known allergy for prednisolone * Acute bacterial infection or parasite infection * Active COVID infection * Systemic sclerosis * Ulcus ventriculi or ulcus duodeni in medical history * Obesity with BMI \>40 * Some drugs are known to interact with Prednisolone, and thus women on the following drugs are not eligible to take part in the PREMI trial: * Enzyme inducers, such as carbamazepine, fenobarbital, fenytoïne and ri-fampicine * CYP3A inhibitors, such as Cobicistat or Ritonavir * Cyclosporine * Digoxin * Vaccination (with inactivated virus or bacteria) during prednisolone use is possibly less effective

Locations (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands