Pre-Eclampsia Clinical Trial
Official title:
Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology
Verified date | August 2023 |
Source | RenJi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Not yet recruiting |
Enrollment | 359 |
Est. completion date | December 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite morbidity | Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension | Gestational period | |
Secondary | fetal growth restriction | <10th percentile for gestational age | 37 weeks of gestational age | |
Secondary | Preterm delivery | Delivery before 37 weeks | 37 weeks of gestational age | |
Secondary | 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 |
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