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The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06383858
Enrollment
50000
Registered
2024-04-25
Start date
2023-08-01
Completion date
2028-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia, Maternal Deaths

Keywords

Preeclampsia, Placental growth factor (PlGF), Real-World Study, Screening, Prevention

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTScreening method

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

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Preeclampsia42 days after deliveryThe 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.

Secondary

MeasureTime frameDescription
Premature birth<37 weeksPremature infants refer to all live births with a gestational age of\<37 weeks
Fetal Growth Restriction42 days after deliveryAffected 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.
Severe complications of preeclampsia42 days after deliveryWhen untreated, severe complications may occur in preeclampsia, such as eclampsia, liver rupture, stroke, pulmonary edema, or renal failure,

Countries

China

Contacts

Primary ContactDunjin Chen, Professor
gzdrchen@gzhmu.edu.cn18928916722
Backup ContactFang He, M.D
hefangjnu@126.com13724831279

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026