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OpenTrials
Active, Not Recruiting

NCT Number: NCT06020378

Hydroxychloroquine May be Beneficial for Preeclampsia

The purpose of this research is to investigate the impact of hydroxychloroquine on the incidence of hypertensive pregnancy disorders in women with a history of recurrent spontaneous abortion (RSA).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai Jiao Tong University School of Medicine,Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

About this study

Preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000 maternal deaths annually, remaining an important cause of death and complications for the mother and baby. However, no treatment yet has been found that affects disease progression except for termination of pregnancy which may cause iatrogenic preterm labor. Therefore, keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed.

Hydroxychloroquine (HCQ), an antimalarial drug, is commonly used in the treatment of pregnant women with RSA and has proven to be safe for both the mother and the fetus. Because of the antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of HCQ, it has been thought to be beneficial in the prevention of preeclampsia.

Therefore, we conducted a retrospective cohort study to evaluate the impact of HCQ treatment on the prevention of preeclampsia in RSA pregnancies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnant women
  • with a history of two or more miscarriages

Exclusion criteria

  • indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, malignancy,
  • major malformation of the fetus diagnosed at 11-13 weeks of gestation.
  • Known paternal, maternal, or embryo chromosome abnormality;
  • Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy;
  • Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine was administered during pregnancy

Other names: Plaquenil

Primary outcomes

  1. Composite morbidity

    Time frame: Gestational period

    Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension

Secondary outcomes

  1. fetal growth restriction

    Time frame: 37 weeks of gestational age

    <10th percentile for gestational age

  2. Preterm delivery

    Time frame: 37 weeks of gestational age

    Delivery before 37 weeks

  3. Abruptio placenta

    Time frame: 37 weeks of gestational age

    The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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