Background 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. 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. Methods The 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. Discussion This 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 registration ClinicalTrials.gov NCT03671174 . Registered on 14 September 2018.
【저자키워드】 Randomized controlled trial, Hydroxychloroquine, Prednisone, Recurrent pregnancy loss, Recurrent spontaneous abortion, Undifferentiated connective tissue disease, 【초록키워드】 Randomized controlled trial, Inflammation, Efficacy, anticoagulation, Open-label, Hydroxychloroquine, Prognosis, progression, outcome, immune, Pregnancy, low-dose, Patient, Controlled trial, placental, Prednisone, HCQ, women, multicenter, disease, patients, Immunosuppressant, abortion, Anticoagulant, Evidence, Vascular damage, regimen, spontaneous abortion, connective tissue disease, live births, Activation, Primary outcome, Trial registration, Secondary outcomes, open-label randomized controlled trial, morbidities, connective tissue, Arm, Prevent, secondary, Randomly, defined, evaluate, include, addition, induce, assigned, Undifferentiated, eligible patient, 【제목키워드】 protocol, Trial, Hydroxychloroquine, Pregnancy, low-dose, Prednisone, women, multicenter, regimen, treat, connective tissue,