Immunosuppressant Regimens for Living Fetuses Study
- Conditions
- Undifferentiated Connective Tissue DiseaseRecurrent Pregnancy Loss
- Interventions
- Registration Number
- NCT03671174
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prednisone + hydroxychloroquine + anticoagulation low molecular weight heparin Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Hydroxychloroquine + anticoagulation low molecular weight heparin Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Anticoagulation low molecular weight heparin Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Prednisone + hydroxychloroquine + anticoagulation Prednisone Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Prednisone + hydroxychloroquine + anticoagulation Aspirin Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Prednisone + hydroxychloroquine + anticoagulation Hydroxychloroquine Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Hydroxychloroquine + anticoagulation Hydroxychloroquine Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Hydroxychloroquine + anticoagulation Aspirin Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin Anticoagulation Aspirin Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
- Primary Outcome Measures
Name Time Method Live birth rate After 28 weeks of gestation Percentage of all cycles that lead to live birth
- Secondary Outcome Measures
Name Time Method Rate of miscarriage Within 28 weeks of gestation Spontaneous pregnancy loss within 28 weeks of gestation, confirmed by pelvic ultrasound findings. This includes no yolk sac or embryo in a gestational sac and an embryo without cardiac activity.
Number of newborns with treatment-related adverse events assessed by 3 parameters post-partum 6 weeks assess the number of the newborns with abnormal vision, hearing and length at 6 weeks
Premature birth between 28 and 37 weeks of gestations live birth between 28 and 37 weeks of gestations Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria \> 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Intrauterine growth retardation between 28 and 37 weeks of gestations weight below the 10th percentile for the gestational age Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria \> 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Gestational age and weight at birth post-partum 6 weeks the children's gestational age and weight at birth
Survival at 28 days post-partum 6 weeks still alive at 28 days
Congenital abnormality post-partum 6 weeks congenital heart conduction block, neonatal lupus or malformation
Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of Sjogren's syndrome
Eclampsia After 20 weeks of gestation New-onset hypertension after 20 weeks of gestation, with or without proteinuria \> 300mg/24h, with or without any organ damage with seizures
Number of participants with Infection through study completion, an average of 1.5 years Infection of respiratory tract, digestive tract, urinary tract and skin
Gestational diabetes mellitus through study completion, an average of 1.5 years Clinical diagnosis of gestational diabetes mellitus
Activity of UCTD through study completion, an average of 1.5 years New onset or aggravation of symptoms like arthritis, rash, Reynolds phenomenon, proteinuria, etc.
Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of systemic lupus erythematosus
Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of systemic sclerosis
Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of polymyositis or dermatomyositis
Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of antiphospholipid syndrome
Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of rheumatoid arthritis
Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD) post-partum 6 weeks Clinical diagnosis of mixed connective tissue disease
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, Shanghai, China