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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.
Details
| Lead sponsor | RenJi Hospital |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 420 |
| Start date | 2019-08-02 |
| Completion | 2023-02 |
Conditions
- Undifferentiated Connective Tissue Disease
- Recurrent Pregnancy Loss
Interventions
- Prednisone
- Hydroxychloroquine
- Aspirin
- low molecular weight heparin
Primary outcomes
- Live birth rate — After 28 weeks of gestation
Percentage of all cycles that lead to live birth
Countries
China