A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome
NCT ID: NCT04624269
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
384 participants
INTERVENTIONAL
2020-12-01
2023-02-01
Brief Summary
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Detailed Description
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The Hydroxychloroquine sulfate(HCQ) group is the test group. Hydroxychloroquine sulfate 0.2g/d (sig: 0.1g bid po) will be applied 3 months before pregnancy, pregnancy will be started at the 4th month, and aspirin 50mg/d will be added after menstruation( sig: 25mg bid po), low molecular weight heparin 4000-6000 U/d after ovulation or 1 week before embryo transplantation; the placebo group is the control group, and placebo 0.2g/d (sig: 0.1 g bid po) from the fourth month of pregnancy, add aspirin 50mg/d (sig: 25mg bid po) after menstruation, and add low molecular heparin 4000-6000 U/d after ovulation or 1 week before embryo transplantation Both groups were followed up by telephone every 1 month to obtain medication compliance, whether there were adverse reactions, etc., and both oth groups were followed up every 3 months for non-pregnant women by outpatient service , until pregnancy. If the patient is not pregnant within one year, The clinical study of this patient will be terminated, and the patients will be followed up for adverse reactions by telephone one month and three months after withdrawal. If you are pregnant, follow up in the first trimester immediately, and arrange a follow-up every three months thereafter (defined as follow-up in the first trimester, follow-up in the second trimester and follow-up in the third trimester). The drug was discontinued on the day of delivery and the postpartum follow-up was completed 6 weeks after delivery. So, therefore, the entire study time is approximately 27 months.
The researcher mainly records the subjects' vital signs, laboratory indicators, adverse events and combined medications, as well as related indicators of pregnancy check-ups (such as uterine artery blood flow, presence or absence of pregnancy complications, fetal complications, etc.)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hydroxychloroquine sulfate Tablets
drug:Hydroxychloroquine sulfate Tablets,0.1mg bid po
Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
placebo
drug:placebo,0.1mg bid po
Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
Interventions
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Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agree to join the study and sign the informed consent of the study.
Exclusion Criteria
* Allergies or adverse events to Hydroxychloroquine(HCQ),such as allergies to the active substance -aminoquinoline or allergies to HCQ or any other chemical components of placebo.
* Patients with any changes in the retina or visual field caused by treatment with 4-aminoquinoline compounds;
* HCQ is currently being used
* Weight \<45kg
* Psoriasis
* Uncontrolled epilepsy
* Anti-ENA antibody positive
* Renal replacement therapy
* Other serious active complications (human immunodeficiency virus, hepatitis B)
* Porphyria
* History of retinopathy
* History of galactose intolerance, history of lactase deficiency, or history of glucose-galactose malabsorption
* Participate in any other clinical trial drug research at the same time.
* Previous treatment failure with Hydroxychloroquin
* Others: such as poor compliance, or those who cannot be followed up on schedule due to certain factors.
18 Years
45 Years
FEMALE
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Fudan University
OTHER
Zhejiang Provincial People's Hospital
OTHER
Zhejiang Provincial Tongde Hospital
OTHER
Shanghai First Maternity and Infant Hospital
OTHER
Responsible Party
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Principal Investigators
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Bao shihua, doctor
Role: STUDY_CHAIR
shanghai First Maternity and Infant Hospital, Tongji University School of Medicin
Locations
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shanghai First Maternity and Infant Hospital, Tongji University School of Medicin
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Shihua Bao
Role: primary
References
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Mak A, Cheung MW, Cheak AA, Ho RC. Combination of heparin and aspirin is superior to aspirin alone in enhancing live births in patients with recurrent pregnancy loss and positive anti-phospholipid antibodies: a meta-analysis of randomized controlled trials and meta-regression. Rheumatology (Oxford). 2010 Feb;49(2):281-8. doi: 10.1093/rheumatology/kep373. Epub 2009 Dec 4.
Sciascia S, Branch DW, Levy RA, Middeldorp S, Pavord S, Roccatello D, Ruiz-Irastorza G, Tincani A, Khamashta M, Schreiber K, Hunt BJ. The efficacy of hydroxychloroquine in altering pregnancy outcome in women with antiphospholipid antibodies. Evidence and clinical judgment. Thromb Haemost. 2016 Jan;115(2):285-90. doi: 10.1160/TH15-06-0491. Epub 2015 Sep 17.
Abarientos C, Sperber K, Shapiro DL, Aronow WS, Chao CP, Ash JY. Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy. Expert Opin Drug Saf. 2011 Sep;10(5):705-14. doi: 10.1517/14740338.2011.566555. Epub 2011 Mar 22.
Mekinian A, Lazzaroni MG, Kuzenko A, Alijotas-Reig J, Ruffatti A, Levy P, Canti V, Bremme K, Bezanahary H, Bertero T, Dhote R, Maurier F, Andreoli L, Benbara A, Tigazin A, Carbillon L, Nicaise-Roland P, Tincani A, Fain O; SNFMI and the European Forum on Antiphospholipid Antibodies. The efficacy of hydroxychloroquine for obstetrical outcome in anti-phospholipid syndrome: Data from a European multicenter retrospective study. Autoimmun Rev. 2015 Jun;14(6):498-502. doi: 10.1016/j.autrev.2015.01.012. Epub 2015 Jan 21.
Branch DW, Peaceman AM, Druzin M, Silver RK, El-Sayed Y, Silver RM, Esplin MS, Spinnato J, Harger J. A multicenter, placebo-controlled pilot study of intravenous immune globulin treatment of antiphospholipid syndrome during pregnancy. The Pregnancy Loss Study Group. Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):122-7. doi: 10.1016/s0002-9378(00)70500-x.
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.
Other Identifiers
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ShanghaiFMIH-HCQ
Identifier Type: -
Identifier Source: org_study_id