Clinical trial NCT06383858: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center
Official title: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Maternal Deaths
Keywords: Preeclampsia
Placental growth factor (PlGF)
Real-World Study
Screening
Prevention
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 50000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women ≥18 years old

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.

Eligibility criteria: 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 outcomes:
measure: Preeclampsia
timeFrame: 42 days after delivery
Secondary outcomes:
measure: Premature birth
timeFrame: <37 weeks
measure: Fetal Growth Restriction
timeFrame: 42 days after delivery
measure: Severe complications of preeclampsia
timeFrame: 42 days after delivery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: FANG HE
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Guangzhou Medical University
name: Dunjin Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: