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A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome

NCT04624269 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2020-11-10

No results posted yet for this study

Summary

The efficacy of low-dose aspirin combined with low-molecular-weight heparin treatment for improving antiphospholipid syndrome and maternal-fetal outcome of patients is recognized by various countries and recommended by the guidelines. However, there are still 20-30% of APS patients whose treatment fails. Therefore, the standard treatment effect is still not ideal, and other treatment options need to be explored. The purpose of this study is to conduct a randomized double-blind, parallel controlled study of patients with recurrent miscarriage and APS in addition to standard treatment, plus hydroxychloroquine sulfate (HCQ) or placebo, to observe the effects of HCQ on pregnancy outcome in patients with abortion and APS, to evaluate the effectiveness and safety of HCQ treatment.

Conditions

  • Antiphospholipid Syndrome
  • Recurrent Miscarriage

Interventions

DRUG

Hydroxychloroquine Sulfate Tablets

Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Zhejiang Provincial Tongde Hospital

    collaborator OTHER

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Principal Investigators

  • Bao shihua, doctor · shanghai First Maternity and Infant Hospital, Tongji University School of Medicin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-11-01
Completion
2023-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624269 on ClinicalTrials.gov