Hydroxychloroquine May be Beneficial for Preeclampsia

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Pre-Eclampsia

Treatments: Drug: Hydroxychloroquine

Study type: Observational

Funder types: Other

Identifiers

NCT06020378

IIT-2022-0186

Details and patient eligibility

About

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).

Full 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.

Enrollment: 462 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

462 participants in 2 patient groups

Hydroxychloroquine treatment group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Hydroxychloroquine nontreatment group

Description:

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