The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

NCT06383858 · tracked via the Priya Life Science China tracker

Sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Phase

Observational

Started

2023-08-01

Last updated

2024-09-19

Condition(s) studied

PreeclampsiaMaternal Deaths

Investigational drug(s) / intervention(s)

Screening methodScreening method

Screening method: All pregnant women in the group were screened for pre-eclampsia risk according to the clinical risk factors listed in NICE Guidelines (2019).

Screening method: In the first trimester, pregnant women with routine MAP and PLGF (with UtA-PI detection conditions plus UtA-PI) were tested, and the risk of preeclampsia was evaluated based on Bayes rule combined with maternal factors. In the second and third trimester of pregnancy, routine determination of PLGF or sFlt-1/PLGF was used to evaluate the risk of preeclampsia.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * 1\) Pregnant women who have been screened for pre-eclampsia risk according to the clinical risk factors listed in NICE guidelines (2019); * 2\) Based on the authoritative guideline of Figo and the consensus of experts in China, pregnant women who routinely use maternal factor +MAP＋PLGF±UtA-PI in the first trimester or PLGF or sFlt-1/PLGF in the second and third trimesters to assess the risk of preeclampsia. * 3\) Meet any of the above conditions, join the group voluntarily, and sign the informed consent form. Exclusion Criteria: * 1\) Severe fetal malformation or abnormality (no fetal heartbeat); * 2\) Those who regularly use aspirin before joining the group; * 3\) There are obvious other abnormal signs, laboratory tests or other clinical d• iseases, which are judged by the researcher to be not suitable for participating in researchers; * 4\) Unable to obtain follow-up and delivery information.

Primary outcome measure(s)

Preeclampsia — 42 days after delivery
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.

Trial sites (1)

Facility	City	Region	Status
FANG HE	Guangzhou	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06383858 on ClinicalTrials.gov ↗ ← All trials in China