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Search / Trial NCT04275778

HYDROxychloroquine in Syndrome Primary AntiPhospholipid

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 17, 2020

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Aps Anticoagulants Pregancy Heparin Low Molecular Weight Aspirin

ClinConnect Summary

This clinical trial, titled "HYDROxychloroquine in Syndrome Primary AntiPhospholipid," is investigating whether adding hydroxychloroquine (HCQ) to standard treatment improves pregnancy outcomes for women with Antiphospholipid Syndrome (APS). APS is a condition that can cause serious complications during pregnancy, including miscarriages and premature births. Current treatments, which often include aspirin and a type of blood thinner, help many women achieve successful pregnancies, but some still face complications. Researchers want to see if adding HCQ, known for its anti-inflammatory and blood-thinning properties, can further enhance the chances of a healthy pregnancy.

To participate in this study, women aged 18 and older who are currently pregnant and have experienced certain serious pregnancy complications related to APS may be eligible. However, those with specific medical conditions, such as a history of eye problems related to hydroxychloroquine, or who are already taking this medication, cannot join the trial. Participants will receive either hydroxychloroquine or standard care and will be monitored throughout their pregnancy. This study aims to provide more options and improve outcomes for women facing the challenges of APS during pregnancy.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age \>18 years
  • Spontaneous consecutive pregnancy ongoing before the 14th week of gestation
  • -- SAPL obstetrics (modified Sapporo criteria = Sydney criteria) with fetal death ≥10 weeks of gestation without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity \<34SA with placental insufficiency (with or without thrombotic SAPL)
  • Signed informed consent
  • Exclusion Criteria:
  • Other SAPL subgroups: early isolated miscarriages \<10 weeks
  • * Contraindication to hydroxychloroquine:
  • retinopathy,
  • hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose
  • Associated systemic lupus, associated Sjogren syndrome
  • Treatment with hydroxychloroquine in progress
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Lack of Social Insurance

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Arsène MEKINIAN, MD

Principal Investigator

Internal Medecine_Hospital Saint Antoine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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