The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Maternal Deaths

Detailed Description

The purpose of this study is to evaluate the impact of a risk assessment and management plan for preeclampsia based on placental growth factor (PlGF) detection in the real medical world on the incidence of preeclampsia, maternal mortality rate, and severe complications of preeclampsia, and to establish appropriate preeclampsia risk screening and prevention standards and guidelines for the Chinese population, in order to reduce the probability of maternal and fetal mortality and long-term chronic diseases.

• Study Type: Observational
• Enrollment (Estimated): 50000

Contacts and Locations

• Study Contact: Name: FANG HE, M.D; Phone Number: 13724831279; Email: hefangjnu@126.com
• Study Contact Backup: Name: Dunjin Chen, Professor; Phone Number: 18928916722; Email: gzdrchen@gzhmu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510150
      • Recruiting
      • Fang He
      • Contact: FANG HE, M.D; Phone Number: 13724831279; Email: hefangjnu@126.com
      • Contact: Qingwen Nie, Master; Phone Number: 15622149953; Email: qw0621n@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Pregnant women ≥18 years old

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pregnant women with low risk of preeclampsia; Preeclampsia risk assessment should be conducted at 11-13+6 weeks and 20-36+6 weeks of pregnancy. For low-risk pregnant women (PlGF≥100pg/ml or sFlt-1 /PlGF <38), it is recommended to closely monitor maternal blood pressure and undergo routine prenatal examinations. In the study, basic information of pregnant women, medical and obstetric history, physical examination information, ultrasound examination data, serum marker (PlGF, sFlt-1) examination results, preeclampsia risk assessment results, medication history, etc. were collected.
Pregnant women with high risk of preeclampsia; Preeclampsia risk assessment should be conducted at 11-13+6 weeks and 20-36+6 weeks of pregnancy.For high-risk pregnant women (PlGF<100pg/ml or sFlt-1/PlGF ≥ 38), close attention should be paid to changes in maternal blood pressure and proteinuria. If necessary, dynamic monitoring of PlGF or sFlt-1/PlGF should be performed, and baseline information should also be registered after enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature birth	Premature infants refer to all live births with a gestational age of<37 weeks	<37 weeks
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
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

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Dunjin Chen, Professor, The Third Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Screening; Prevention; Preeclampsia; Placental growth factor (PlGF); Real-World Study
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Death; Parental Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Maternal Death
• Other Study ID Numbers: [2023] Ethics Review NO.151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No