ArticleTrials2020
A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03671174 (A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases), which is not on this map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
8 citing papers in PubMed, 23 citations in OpenAlex.
- Trial
- Effects of hydroxychloroquine sulfate combined with aspirin and enoxaparin sodium therapy on perinatal outcomes in patients with undifferentiated connective tissue disease-related recurrent miscarriage: a retrospective clinical study.BMC pregnancy and childbirth · 2026Article
- Autoimmune Disorders and Thrombophilia in Pathologic Pregnancies: Management Throughout the Full Gestation.Biomedicines · 2026Article
- Hydroxychloroquine for preventing hypertensive pregnancy disorders in recurrent spontaneous abortion: a retrospective cohort study in a single referral center.European journal of medical research · 2025Article
- Hydroxychloroquine in recurrent pregnancy loss: data from a French prospective multicenter registry.Human reproduction (Oxford, England) · 2024Article
- A real-world disproportionality analysis of cyclosporine from the FDA Adverse Event Reporting System (FAERS) database.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2024Article
- Undifferentiated Connective Tissue Disease in Pregnancy: A Topic Yet to be Explored.Frontiers in pharmacology · 2022Review
- Long Noncoding RNA RP11-115N4.1 Promotes Inflammatory Responses by Interacting With HNRNPH3 and Enhancing the Transcription of HSP70 in Unexplained Recurrent Spontaneous Abortion.Frontiers in immunology · 2021Article
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Authors and funding
7 authors at 4 institutions in 3 countries.
Funding
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. 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 registrationClinicalTrials.gov NCT03671174 . Registered on 14 September 2018.
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