Hydroxychloroquine May be Beneficial for Preeclampsia

Study Overview
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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.

Official Title
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Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnant women with a history of two or more miscarriages Exclusion Criteria: 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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hydroxychloroquine treatment group<br>The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy. | Drug: Hydroxychloroquine<br>* Hydroxychloroquine was administered during pregnancy<br>* Other names: Plaquenil;|
| Hydroxychloroquine nontreatment group<br>The Hydroxychloroquine nontreatment group was defined as having no exposure to Hydroxychloroquine during pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite morbidity | Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension | Gestational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal growth restriction | <10th percentile for gestational age | 37 weeks of gestational age | 
| Preterm delivery | Delivery before 37 weeks | 37 weeks of gestational age | 
| Abruptio placenta | The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy | 37 weeks of gestational age |