Recurrent Pregnancy Loss Clinical Trial
Official title:
A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtuses (ILIFE) Trial
Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Therefore, based on the tendency to thrombosis formation and placental inflammation in the pathogenesis of UCTD, this trial proposes to evaluate the effect of hydroxychloroquine with or without prednisone combined with anticoagulation on pregnancy outcomes in recurrent pregnancy loss patients with UCTD.
Objective: To evaluate the effect of anticoagulation with or without immunomodulatory therapy
on pregnancy outcomes of recurrent pregnancy loss with undifferentiated connective tissue
diseases Design: a multi-center, randomised, open-label, paralleled study. Patients: Pregnant
patients with recurrent pregnancy loss and undifferentiated connective tissue diseases
without any known etiology for pregnancy loss (detailed in section 10).
Methods: 420 selected patients are divided into 3 parallel groups (detailed in section 8).
Randomization: Patients who present to relevant clinics for management of recurrent
spontaneous abortion (RSA) will be evaluated for inclusion criteria and exclusion criteria by
a formed physician. Once patient is eligible for the study, the co-investigator will obtain
written patient's consent. Participants will be randomized into one of the 3 groups.
Randomized numbers will be generated by pharmacology research personnel in Renji Hospital.
Given the different administrated medications, neither the patient nor the provider will be
blinded.
Follow-up: Consultation will be scheduled every 4 weeks from confirmed pregnancy until
delivery. The co-investigator will complete a follow-up survey including clinical, biological
data.
Missing data: Patients are willing to drop the study, unavailable, incompliant, with severe
complications or with severe adverse effects. The missing data will be recorded in detail and
be analysed with last pregnancy outcome.
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