Abstract
BackgroundUndifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Anticoagulation can prevent pregnancy morbidities. However, it is unknown whether the addition of immune suppressants to anticoagulation can prevent spontaneous pregnancy loss in UCTD patients. The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and low-dose prednisone on recurrent pregnancy loss for women with UCTD.MethodsThe Immunosuppressant for Living Fetuses (ILIFE) Trial is a three-arm, multicenter, open-label randomized controlled trial with the primary objective of comparing hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone in treating UCTD women with recurrent spontaneous abortion. The third arm of using hydroxychloroquine combined with anticoagulant for secondary comparison. A total of 426 eligible patients will be randomly assigned to each of the three arms with a 1:1:1 allocation ratio. The primary outcome is the rate of live births. Secondary outcomes include adverse pregnancy outcomes and progression of UCTD.DiscussionThis is the first multi-center, open-label, randomized controlled trial which evaluates the efficacy of immunosuppressant regimens on pregnancy outcomes and UCTD progression. It will provide evidence on whether the immunosuppressant ameliorates the pregnancy prognosis in UCTD patients with RSA and the progression into defined connective tissue disease.Trial registrationClinicalTrials.gov NCT03671174. Registered on 14 September 2018.
Highlights
Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation
Yang et al Trials (2020) 21:771 (Continued from previous page). This is the first multi-center, open-label, randomized controlled trial which evaluates the efficacy of immunosuppressant regimens on pregnancy outcomes and UCTD progression
UCTD may evolve into definite connective tissue diseases (CTDs) like systemic lupus erythematosus (SLE), systemic sclerosis, primary Sjögren’s syndrome, mixed connective tissue disease, systemic vasculitis, polymyositis, and rheumatoid arthritis [6]
Summary
Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Antinuclear antibodies and inflammation in UCTD may impair platelet activity, unbalance coagulation/anticoagulation, increase the risk of thrombosis, and cause collagen synthesis defect and endothelial dysfunction [8,9,10]. It could increase uterine artery resistance, inhibit placenta development and remodeling, and increase the risk of preeclampsia, intrauterine growth retardation (IUGR), small for gestational age infant (SGA), and recurrent spontaneous abortion (RSA) [3, 11,12,13,14]. Other studies reported that the prevalence of adverse pregnancy outcomes ranged from 27 to 30% in women with UCTD [13, 16]
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