Back to resultsImmunosuppressant Regimens for Living Fetuses Study
Primary Purpose
Undifferentiated Connective Tissue Disease, Recurrent Pregnancy Loss
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone
Hydroxychloroquine
Aspirin
low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Undifferentiated Connective Tissue Disease
Eligibility Criteria
Inclusion criteria
Women who meet the following inclusion criteria will be eligible to participate in the study:
- At reproductive age (20-40 years old).
- Trying to conceive.
- 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.
- Diagnosed with RSA[39]: two or more failed pregnancies of unknown origin.
- Providing written informed consent. Exclusion criteria
Women who meet any of the following criteria will be excluded from the study:
1.Any known etiology of previous pregnancy loss:
- Diagnosis of antiphospholipid antibody syndrome.
- Known paternal, maternal or embryo chromosome abnormality.
- 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.
- Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.
- 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:
- Active viral hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV).
- 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:
- Past history of digestive ulcers or upper gastrointestinal hemorrhage.
- Past history of malignancy.
- Past history of epilepsia or psychotic disorders. 6.Woman unable to consent or impossible to follow-up.
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Prednisone + hydroxychloroquine + anticoagulation
Hydroxychloroquine + anticoagulation
Anticoagulation
Arm Description
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Outcomes
Primary Outcome Measures
Live birth rate
Percentage of all cycles that lead to live birth
Secondary Outcome Measures
Rate of miscarriage
Spontaneous pregnancy loss within 28 weeks of gestation, confirmed by pelvic ultrasound findings. This includes no yolk sac or embryo in a gestational sac and an embryo without cardiac activity.
Premature birth
live birth between 28 and 37 weeks of gestations Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Intrauterine growth retardation
weight below the 10th percentile for the gestational age Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Gestational age and weight at birth
the children's gestational age and weight at birth
Survival at 28 days
still alive at 28 days
Number of newborns with treatment-related adverse events assessed by 3 parameters
assess the number of the newborns with abnormal vision, hearing and length at 6 weeks
Congenital abnormality
congenital heart conduction block, neonatal lupus or malformation
Eclampsia
New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures
Number of participants with Infection
Infection of respiratory tract, digestive tract, urinary tract and skin
Gestational diabetes mellitus
Clinical diagnosis of gestational diabetes mellitus
Activity of UCTD
New onset or aggravation of symptoms like arthritis, rash, Reynolds phenomenon, proteinuria, etc.
Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of systemic lupus erythematosus
Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of Sjogren's syndrome
Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of systemic sclerosis
Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of polymyositis or dermatomyositis
Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of antiphospholipid syndrome
Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of rheumatoid arthritis
Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD)
Clinical diagnosis of mixed connective tissue disease
Full Information
NCT ID
NCT03671174
First Posted
August 30, 2018
Last Updated
August 8, 2019
Sponsor
RenJi Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, China-Japan Union Hospital, Jilin University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT03671174
Brief Title
Immunosuppressant Regimens for Living Fetuses Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, China-Japan Union Hospital, Jilin University, Wuxi No. 2 People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Objective: To evaluate the effect of anticoagulation with or without immunomodulatory therapy on pregnancy outcomes of recurrent pregnancy loss with undifferentiated connective tissue diseases Design: a multi-center, randomised, open-label, paralleled study. Patients: Pregnant patients with recurrent pregnancy loss and undifferentiated connective tissue diseases without any known etiology for pregnancy loss (detailed in section 10).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undifferentiated Connective Tissue Disease, Recurrent Pregnancy Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone + hydroxychloroquine + anticoagulation
Arm Type
Experimental
Arm Description
Oral low-dose prednisone PLUS Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Arm Title
Hydroxychloroquine + anticoagulation
Arm Type
Experimental
Arm Description
Oral hydroxychloroquine PLUS Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Arm Title
Anticoagulation
Arm Type
Active Comparator
Arm Description
Oral low-dose aspirin PLUS subcutaneous low-molecular-weight heparin
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
10mg once daily orally
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
100mg to 200mg twice daily orally
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
50mg once daily orally
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin
Other Intervention Name(s)
Enoxaparin, Dalteparin, Nadroparin
Intervention Description
Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
Primary Outcome Measure Information:
Title
Live birth rate
Description
Percentage of all cycles that lead to live birth
Time Frame
After 28 weeks of gestation
Secondary Outcome Measure Information:
Title
Rate of miscarriage
Description
Spontaneous pregnancy loss within 28 weeks of gestation, confirmed by pelvic ultrasound findings. This includes no yolk sac or embryo in a gestational sac and an embryo without cardiac activity.
Time Frame
Within 28 weeks of gestation
Title
Premature birth
Description
live birth between 28 and 37 weeks of gestations Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Time Frame
between 28 and 37 weeks of gestations
Title
Intrauterine growth retardation
Description
weight below the 10th percentile for the gestational age Prematurity (live birth between 28 and 37 weeks of gestations); Eclampsia (new-onset hypertension after 20 weeks of gestation, +/- proteinuria > 300mg/24h, with or without any organ damage with seizures); Fetal abnormality (congenital heart conduction block, neonatal lupus or malformation)
Time Frame
between 28 and 37 weeks of gestations
Title
Gestational age and weight at birth
Description
the children's gestational age and weight at birth
Time Frame
post-partum 6 weeks
Title
Survival at 28 days
Description
still alive at 28 days
Time Frame
post-partum 6 weeks
Title
Number of newborns with treatment-related adverse events assessed by 3 parameters
Description
assess the number of the newborns with abnormal vision, hearing and length at 6 weeks
Time Frame
post-partum 6 weeks
Title
Congenital abnormality
Description
congenital heart conduction block, neonatal lupus or malformation
Time Frame
post-partum 6 weeks
Title
Eclampsia
Description
New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures
Time Frame
After 20 weeks of gestation
Title
Number of participants with Infection
Description
Infection of respiratory tract, digestive tract, urinary tract and skin
Time Frame
through study completion, an average of 1.5 years
Title
Gestational diabetes mellitus
Description
Clinical diagnosis of gestational diabetes mellitus
Time Frame
through study completion, an average of 1.5 years
Title
Activity of UCTD
Description
New onset or aggravation of symptoms like arthritis, rash, Reynolds phenomenon, proteinuria, etc.
Time Frame
through study completion, an average of 1.5 years
Title
Number of participants who evolved to systemic lupus erythematosus(SLE) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of systemic lupus erythematosus
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to Sjogren's syndrome(SS) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of Sjogren's syndrome
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to systemic sclerosis(SSc) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of systemic sclerosis
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to polymyositis(PM) or dermatomyositis(DM) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of polymyositis or dermatomyositis
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to antiphospholipid syndrome (APS) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of antiphospholipid syndrome
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to rheumatoid arthritis (RA) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of rheumatoid arthritis
Time Frame
post-partum 6 weeks
Title
Number of participants who evolved to mixed connective tissue disease(MCTD) from undifferentiated connective tissue diseases(UCTD)
Description
Clinical diagnosis of mixed connective tissue disease
Time Frame
post-partum 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Women who meet the following inclusion criteria will be eligible to participate in the study:
At reproductive age (20-40 years old).
Trying to conceive.
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.
Diagnosed with RSA[39]: two or more failed pregnancies of unknown origin.
Providing written informed consent. Exclusion criteria
Women who meet any of the following criteria will be excluded from the study:
1.Any known etiology of previous pregnancy loss:
Diagnosis of antiphospholipid antibody syndrome.
Known paternal, maternal or embryo chromosome abnormality.
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.
Maternal anatomical abnormality: uterine malformation; Asherman syndrome; cervical incompetence; uterine fibrosis more than 5 cm.
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:
Active viral hepatitis including hepatitis B virus (HBV), hepatitis C virus (HCV).
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:
Past history of digestive ulcers or upper gastrointestinal hemorrhage.
Past history of malignancy.
Past history of epilepsia or psychotic disorders. 6.Woman unable to consent or impossible to follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangjing Lu
Phone
+86 13661472001
Email
lu_liangjing@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liangjing Lu
Organizational Affiliation
RenJi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangjing Lu
Phone
+8613661472001
Email
lu_liangjing@163.com
First Name & Middle Initial & Last Name & Degree
Shaoying Yang
Phone
+8613601984013
Email
shaoying_yang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10544849
Citation
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.
Results Reference
background
PubMed Identifier
27457513
Citation
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.
Results Reference
background
PubMed Identifier
28921728
Citation
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.
Results Reference
background
PubMed Identifier
1757934
Citation
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.
Results Reference
result
PubMed Identifier
24917564
Citation
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.
Results Reference
result
PubMed Identifier
27756248
Citation
Spinillo A, Beneventi F, Locatelli E, Ramoni V, Caporali R, Alpini C, Albonico G, Cavagnoli C, Montecucco C. The impact of unrecognized autoimmune rheumatic diseases on the incidence of preeclampsia and fetal growth restriction: a longitudinal cohort study. BMC Pregnancy Childbirth. 2016 Oct 18;16(1):313. doi: 10.1186/s12884-016-1076-8.
Results Reference
result
PubMed Identifier
12090565
Citation
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.
Results Reference
result
PubMed Identifier
18667193
Citation
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.
Results Reference
result
PubMed Identifier
22635227
Citation
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.
Results Reference
result
PubMed Identifier
25280034
Citation
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.
Results Reference
result
PubMed Identifier
19390908
Citation
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.
Results Reference
result
PubMed Identifier
20528832
Citation
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.
Results Reference
result
PubMed Identifier
16716321
Citation
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.
Results Reference
result
PubMed Identifier
24818590
Citation
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.
Results Reference
result
PubMed Identifier
10648016
Citation
Gonzalez-Lopez L, Gamez-Nava JI, Jhangri G, Russell AS, Suarez-Almazor ME. Decreased progression to rheumatoid arthritis or other connective tissue diseases in patients with palindromic rheumatism treated with antimalarials. J Rheumatol. 2000 Jan;27(1):41-6.
Results Reference
result
PubMed Identifier
17075810
Citation
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.
Results Reference
result
PubMed Identifier
25305214
Citation
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.
Results Reference
result
PubMed Identifier
26384980
Citation
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.
Results Reference
result
PubMed Identifier
26429521
Citation
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.
Results Reference
result
PubMed Identifier
20447951
Citation
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.
Results Reference
result
PubMed Identifier
32907619
Citation
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.
Results Reference
derived
Learn more about this trial
Immunosuppressant Regimens for Living Fetuses Study
We'll reach out to this number within 24 hrs