Clinical trial NCT06020378: Hydroxychloroquine May be Beneficial for Preeclampsia
Official title: Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pre-Eclampsia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 462
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with RSA who delivered after 28 weeks from November 2016 to August 2022 at Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite morbidity
timeFrame: Gestational period
Secondary outcomes:
measure: fetal growth restriction
timeFrame: 37 weeks of gestational age
measure: Preterm delivery
timeFrame: 37 weeks of gestational age
measure: Abruptio placenta
timeFrame: 37 weeks of gestational age
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine，Renji Hospital
state: Shanghai
Study officials:
References: