Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 462
- 试验地点
- 1
- 主要终点
- Composite morbidity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnant women
- •with a history of two or more miscarriages
排除标准
- •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,
- •major malformation of the fetus diagnosed at 11-13 weeks of gestation.
- •Known paternal, maternal, or embryo chromosome abnormality;
- •Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that might explain RM in the first trimester of pregnancy;
- •Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.
研究组 & 干预措施
Hydroxychloroquine treatment group
The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy.
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Composite morbidity
时间窗: Gestational period
Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension
次要结局
- fetal growth restriction(37 weeks of gestational age)
- Preterm delivery(37 weeks of gestational age)
- Abruptio placenta(37 weeks of gestational age)