Hydroxychloroquine May be Beneficial for Preeclampsia

NCT ID: NCT06020378

Last Updated: 2025-04-24

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Pre-Eclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hydroxychloroquine treatment group

The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy.

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine was administered during pregnancy

Hydroxychloroquine nontreatment group

The Hydroxychloroquine nontreatment group was defined as having no exposure to Hydroxychloroquine during pregnancy.

No interventions assigned to this group

Interventions

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Hydroxychloroquine

Hydroxychloroquine was administered during pregnancy

Intervention Type DRUG

Other Intervention Names

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Plaquenil

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Jiao Tong University School of Medicine,Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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IIT-2022-0186

Identifier Type: -

Identifier Source: org_study_id

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