The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

Официальное название

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention

Обзор

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.

Подробное описание

The purpose of this study is to evaluate the influence of pre-eclampsia risk screening scheme based on maternal high-risk factors or pre-eclampsia risk assessment and management plan based on placental growth factor (PIGF) detection in the real medical world on the incidence of pre-eclampsia, maternal mortality and severe complications of pre-eclampsia, and to establish appropriate pre-eclampsia risk screening and prevention standards and guidelines for China population, so as to reduce the probability of maternal and fetal death and long-term chronic diseases.

Вмешательства

• Диагностический тест 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).
• Диагностический тест 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.

Первичные конечные точки

• Preeclampsia [Срок оценки: 42 days after delivery]

Вторичные конечные точки (3)

• Premature birth [Срок оценки: <37 weeks]
• Fetal Growth Restriction [Срок оценки: 42 days after delivery]
• Severe complications of preeclampsia [Срок оценки: 42 days after delivery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• FANG HE — Гуанчжоу

Публикации

• Tang J, Xiao D, Yang S, Fang L, Liu H, Chen D, He F. sFlt-1/PlGF Ratio Predicts Short-Term Maternal-Fetal Outcomes in Chinese Hypertensive Pregnancies: A Prospective Cohort Study. Hypertension. 2026 Feb;83(2):e25022. doi: 10.1161/HYPERTENSIONAHA.125.25022. Epub 2025 Sep 15. PMID 40948128

Идентификаторы

NCT: NCT06383858 · [2024] Ethics Review NO.114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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