Hydroxychloroquine May be Beneficial for Preeclampsia

Active, not recruiting

• Conditions: Pre-Eclampsia
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT06020378
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-27
• Study First Posted: 2023-08-31
• Study Start: 2024-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-19
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 462

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Composite morbidity	Gestational period	Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension

Secondary Outcome Measures

Name	Time	Method
fetal growth restriction	37 weeks of gestational age	\<10th percentile for gestational age
Preterm delivery	37 weeks of gestational age	Delivery before 37 weeks
Abruptio placenta	37 weeks of gestational age	The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine，Renji Hospital; 🇨🇳 Shanghai, Shanghai, China