Preeclampsia Clinical Trial
Official title:
The Project of Gestational Hypertension and Preeclampsia Screening and Prevention
Preeclampsia is the main cause of illness and death in pregnant women and fetuses. Currently, there is no effective treatment for preeclampsia in clinical practice, and the fundamental treatment is still termination of pregnancy and placental delivery. Therefore, early prediction of preeclampsia and targeted strengthening of high-risk pregnant women supervision, early intervention and diagnosis and treatment can greatly reduce the serious obstetric complications and perinatal maternal and fetal deaths caused by preeclampsia, which has significant social and clinical significance.
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =18 years old - Pregnant women whose risk of preeclampsia is assessed based on maternal factors + mean arterial pressure (MAP) + placental growth factor (PlGF) ± uterine artery pulsatility index (UtA-PI) at 11-13 weeks of pregnancy or who use PlGF or sFlt-1/PlGF to predict the risk of preeclampsia after 20 weeks of pregnancy - Single pregnancy and fetal survival - Agree to participate and sign the informed consent form Exclusion Criteria: - Severe fetal malformation or abnormality (no fetal heartbeat) - Those with severe mental disorders and unable to express their wishes - There are other obvious abnormal signs, laboratory tests or other clinical diseases, and the researcher determines that they are not suitable to participate in the study - Those who cannot obtain follow-up and delivery information |
Country | Name | City | State |
---|---|---|---|
China | FANG HE | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The Third Affiliated Hospital of Guangzhou Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preeclampsia | The criteria for diagnosis and treatment of Hypertensive diseases in Pregnancy (2020) are implemented according to the Guidelines for Diagnosis and Treatment of Hypertensive Diseases in Pregnancy (2020), that is, systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg after 20 weeks of pregnancy, accompanied by any one of the following: urinary protein quantity =0.3 g/24h, or urinary protein/creatinine ratio =0.3, or random urinary protein = (+); No proteinuria, but accompanied by any of the following organs or systems: heart, lung, liver, kidney and other vital organs, or abnormal changes in the blood system, digestive system, nervous system, placenta - fetal involvement. | 42 days after delivery | |
Secondary | Premature birth | Premature infants refer to all live births with a gestational age of<37 weeks | <37 weeks | |
Secondary | Fetal Growth Restriction | Affected by pathological factors such as maternal, fetal, and placental factors, fetal growth has not reached its expected genetic potential, often manifested as fetal ultrasound estimated weight or abdominal circumference being lower than the 10th percentile of the corresponding gestational age. | 42 days after delivery | |
Secondary | Severe complications of preeclampsia | When untreated, severe complications may occur in preeclampsia, such as eclampsia, liver rupture, stroke, pulmonary edema, or renal failure, | 42 days after delivery |
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