Study Results
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Basic Information
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UNKNOWN
NA
420 participants
INTERVENTIONAL
2019-08-02
2023-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prednisone + hydroxychloroquine + anticoagulation
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Prednisone
10mg once daily orally
Hydroxychloroquine
100mg to 200mg twice daily orally
Aspirin
50mg once daily orally
low molecular weight heparin
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
Hydroxychloroquine + anticoagulation
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Hydroxychloroquine
100mg to 200mg twice daily orally
Aspirin
50mg once daily orally
low molecular weight heparin
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
Anticoagulation
Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Aspirin
50mg once daily orally
low molecular weight heparin
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
Interventions
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Prednisone
10mg once daily orally
Hydroxychloroquine
100mg to 200mg twice daily orally
Aspirin
50mg once daily orally
low molecular weight heparin
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Trying to conceive.
3. Diagnosed with UCTD\[2\]: at least one symptoms or signs suggesting connective tissue disease(CTD) and with at least one presence of auto-antibodies, including antinuclear antibody (ANA), anti-SSA antibody, while not fulfilling any classification criteria of a defined CTD.
4. Diagnosed with RSA\[39\]: two or more failed pregnancies of unknown origin.
Exclusion Criteria
1.Any known etiology of previous pregnancy loss:
1. Diagnosis of antiphospholipid antibody syndrome.
2. Known paternal, maternal or embryo chromosome abnormality.
3. Maternal endocrine dysfunction: corpus luteal insufficiency; polycystic ovarian syndrome; premature ovarian failure (follicle stimulating hormone, FSH ≥20uU/L in follicular phase); hyperprolactinemia; thyroid disease; diabetes mellitus; other hypothalamic-pituitary-adrenal axis abnormality.
4. Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.
5. Vaginal infection. 2.Any known severe cardiac, hepatic, renal, hematological or endocrinal diseases:
(1)Alanine transaminase (ALT) or aspartate transaminase(AST) more than twice the upper limit of normal.
(2)Clearance of creatinine less than 30mL/min. (3)Leucocytes less than 2.5\*10\^9/L, or Hemoglobine less than 85g/L, or Platelet less than 50\~10\^9/L.
3.Any active infection:
1. Active viral hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV).
2. Active infection including V aricella-zostervirus(VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis.
4.Allergic to prednisone, hydroxychloroquine, low-molecular-weight heparin or aspirin.
5.Disease history as follows:
1. Past history of digestive ulcers or upper gastrointestinal hemorrhage.
2. Past history of malignancy.
3. Past history of epilepsia or psychotic disorders. 6.Woman unable to consent or impossible to follow-up.
20 Years
40 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital of Anhui Medical University
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Wuxi No. 2 People's Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
RenJi Hospital
OTHER
Responsible Party
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Liangjing Lu
Professor
Principal Investigators
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Liangjing Lu
Role: STUDY_CHAIR
RenJi Hospital
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Mosca M, Neri R, Bombardieri S. Undifferentiated connective tissue diseases (UCTD): a review of the literature and a proposal for preliminary classification criteria. Clin Exp Rheumatol. 1999 Sep-Oct;17(5):615-20.
Andreoli L, Bertsias GK, Agmon-Levin N, Brown S, Cervera R, Costedoat-Chalumeau N, Doria A, Fischer-Betz R, Forger F, Moraes-Fontes MF, Khamashta M, King J, Lojacono A, Marchiori F, Meroni PL, Mosca M, Motta M, Ostensen M, Pamfil C, Raio L, Schneider M, Svenungsson E, Tektonidou M, Yavuz S, Boumpas D, Tincani A. EULAR recommendations for women's health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017 Mar;76(3):476-485. doi: 10.1136/annrheumdis-2016-209770. Epub 2016 Jul 25.
Spinillo A, Beneventi F, Caporali R, Ramoni V, Montecucco C. Undifferentiated connective tissue diseases and adverse pregnancy outcomes. An undervalued association? Am J Reprod Immunol. 2017 Dec;78(6). doi: 10.1111/aji.12762. Epub 2017 Sep 16.
Alarcon GS, Williams GV, Singer JZ, Steen VD, Clegg DO, Paulus HE, Billingsley LM, Luggen ME, Polisson RP, Willkens RF, et al. Early undifferentiated connective tissue disease. I. Early clinical manifestation in a large cohort of patients with undifferentiated connective tissue diseases compared with cohorts of well established connective tissue disease. J Rheumatol. 1991 Sep;18(9):1332-9.
Laczik R, Soltesz P, Szodoray P, Szekanecz Z, Kerekes G, Paragh G, Rajnavolgyi E, Abel G, Szegedi G, Bodolay E. Impaired endothelial function in patients with undifferentiated connective tissue disease: a follow-up study. Rheumatology (Oxford). 2014 Nov;53(11):2035-43. doi: 10.1093/rheumatology/keu236. Epub 2014 Jun 10.
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Mosca M, Neri R, Strigini F, Carmignani A, Totti D, Tavoni A, Bombardieri S. Pregnancy outcome in patients with undifferentiated connective tissue disease: a preliminary study on 25 pregnancies. Lupus. 2002;11(5):304-7. doi: 10.1191/0961203302lu187oa.
Spinillo A, Beneventi F, Epis OM, Montanari L, Mammoliti D, Ramoni V, Di Silverio E, Alpini C, Caporali R, Montecucco C. The effect of newly diagnosed undifferentiated connective tissue disease on pregnancy outcome. Am J Obstet Gynecol. 2008 Dec;199(6):632.e1-6. doi: 10.1016/j.ajog.2008.05.008. Epub 2008 Jul 29.
Alijotas-Reig J, Ferrer-Oliveras R; EUROAPS Study Group. The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): a preliminary first year report. Lupus. 2012 Jun;21(7):766-8. doi: 10.1177/0961203312440058.
Proietta M, Ferrero S, Ferri L, Cifani N, Bruno G, Del Porto F. Recurrent miscarriages in women not fulfilling classification criteria for antiphospholipid antibody syndrome. Int J Immunopathol Pharmacol. 2014 Jul-Sep;27(3):429-32. doi: 10.1177/039463201402700313.
Vaz CC, Couto M, Medeiros D, Miranda L, Costa J, Nero P, Barros R, Santos MJ, Sousa E, Barcelos A, Ines L. Undifferentiated connective tissue disease: a seven-center cross-sectional study of 184 patients. Clin Rheumatol. 2009 Aug;28(8):915-21. doi: 10.1007/s10067-009-1175-2. Epub 2009 Apr 24.
Bansal AS. Joining the immunological dots in recurrent miscarriage. Am J Reprod Immunol. 2010 Nov;64(5):307-15. doi: 10.1111/j.1600-0897.2010.00864.x.
Tempfer CB, Kurz C, Bentz EK, Unfried G, Walch K, Czizek U, Huber JC. A combination treatment of prednisone, aspirin, folate, and progesterone in women with idiopathic recurrent miscarriage: a matched-pair study. Fertil Steril. 2006 Jul;86(1):145-8. doi: 10.1016/j.fertnstert.2005.12.035. Epub 2006 May 23.
Gomaa MF, Elkholy AG, El-Said MM, Abdel-Salam NE. Combined oral prednisolone and heparin versus heparin: the effect on peripheral NK cells and clinical outcome in patients with unexplained recurrent miscarriage. A double-blind placebo randomized controlled trial. Arch Gynecol Obstet. 2014 Oct;290(4):757-62. doi: 10.1007/s00404-014-3262-0. Epub 2014 May 13.
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Clowse ME, Magder L, Witter F, Petri M. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum. 2006 Nov;54(11):3640-7. doi: 10.1002/art.22159.
Koh JH, Ko HS, Kwok SK, Ju JH, Park SH. Hydroxychloroquine and pregnancy on lupus flares in Korean patients with systemic lupus erythematosus. Lupus. 2015 Feb;24(2):210-7. doi: 10.1177/0961203314555352. Epub 2014 Oct 10.
Luo Y, Zhang L, Fei Y, Li Y, Hao D, Liu Y, Zhao Y. Pregnancy outcome of 126 anti-SSA/Ro-positive patients during the past 24 years--a retrospective cohort study. Clin Rheumatol. 2015 Oct;34(10):1721-8. doi: 10.1007/s10067-015-3050-7. Epub 2015 Aug 26.
Sciascia S, Hunt BJ, Talavera-Garcia E, Lliso G, Khamashta MA, Cuadrado MJ. The impact of hydroxychloroquine treatment on pregnancy outcome in women with antiphospholipid antibodies. Am J Obstet Gynecol. 2016 Feb;214(2):273.e1-273.e8. doi: 10.1016/j.ajog.2015.09.078. Epub 2015 Sep 30.
Izmirly PM, Kim MY, Llanos C, Le PU, Guerra MM, Askanase AD, Salmon JE, Buyon JP. Evaluation of the risk of anti-SSA/Ro-SSB/La antibody-associated cardiac manifestations of neonatal lupus in fetuses of mothers with systemic lupus erythematosus exposed to hydroxychloroquine. Ann Rheum Dis. 2010 Oct;69(10):1827-30. doi: 10.1136/ard.2009.119263. Epub 2010 May 6.
Yang S, Ni R, Lu Y, Wang S, Xie F, Zhang C, Lu L. 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. Trials. 2020 Sep 9;21(1):771. doi: 10.1186/s13063-020-04716-1.
Other Identifiers
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ILIFE Study
Identifier Type: -
Identifier Source: org_study_id
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