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
试验速览
- 阶段
- 不适用
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hydroxychloroquine + anticoagulation
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: low molecular weight heparin (Drug)
Prednisone + hydroxychloroquine + anticoagulation
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Prednisone (Drug)
Prednisone + hydroxychloroquine + anticoagulation
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Hydroxychloroquine (Drug)
Prednisone + hydroxychloroquine + anticoagulation
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Aspirin (Drug)
Prednisone + hydroxychloroquine + anticoagulation
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: low molecular weight heparin (Drug)
Hydroxychloroquine + anticoagulation
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Hydroxychloroquine (Drug)
Hydroxychloroquine + anticoagulation
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Aspirin (Drug)
Anticoagulation
Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: Aspirin (Drug)
Anticoagulation
Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
干预措施: low molecular weight heparin (Drug)
结局指标
主要结局
Live birth rate
时间窗: After 28 weeks of gestation
Percentage of all cycles that lead to live birth
次要结局
- Rate of miscarriage(Within 28 weeks of gestation)
- Number of newborns with treatment-related adverse events assessed by 3 parameters(post-partum 6 weeks)
- Premature birth(between 28 and 37 weeks of gestations)
- Intrauterine growth retardation(between 28 and 37 weeks of gestations)
- Gestational age and weight at birth(post-partum 6 weeks)
- Survival at 28 days(post-partum 6 weeks)
- Congenital abnormality(post-partum 6 weeks)
- Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Eclampsia(After 20 weeks of gestation)
- Number of participants with Infection(through study completion, an average of 1.5 years)
- Gestational diabetes mellitus(through study completion, an average of 1.5 years)
- Activity of UCTD(through study completion, an average of 1.5 years)
- Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)
- Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD)(post-partum 6 weeks)