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Hydroxychloroquine May be Beneficial for Preeclampsia

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06020378
Enrollment
462
Registered
2023-08-31
Start date
2024-01-01
Completion date
2026-12-01
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Brief summary

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).

Detailed description

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.

Interventions

DRUGHydroxychloroquine

Hydroxychloroquine was administered during pregnancy

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

1. singleton pregnant women 2. with a history of two or more miscarriages

Exclusion criteria

1. 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, 2. major malformation of the fetus diagnosed at 11-13 weeks of gestation. 3. Known paternal, maternal, or embryo chromosome abnormality; 4. Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy; 5. Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.

Design outcomes

Primary

MeasureTime frameDescription
Composite morbidityGestational periodPreeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension

Secondary

MeasureTime frameDescription
fetal growth restriction37 weeks of gestational age\<10th percentile for gestational age
Preterm delivery37 weeks of gestational ageDelivery before 37 weeks
Abruptio placenta37 weeks of gestational ageThe number of cases of abruptio placenta that appear in both groups at any given time during pregnancy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026