The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

NCT06383858 | Recruiting

• 1 other identifier: [2024] Ethics Review NO.114
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Maternal Deaths

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Premature birth

  <37 weeks

• Fetal Growth Restriction

  42 days after delivery

• Severe complications of preeclampsia

  42 days after delivery

Study Arms (2)

Screening based on maternal factors

Pregnant women with low risk of pre-eclampsia assessment and no suspected pre-eclampsia symptoms in the later period are only followed up at delivery to register the outcome indicators. For pregnant women with high risk of preeclampsia evaluation, it is necessary to register the history of drug use (whether or not to use and the dosage), and follow up to register the outcome index at delivery.

Diagnostic Test: Screening method

Screening based on FMF model

Preeclampsia risk assessment should be carried out 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 suggested to closely monitor maternal blood pressure and conduct routine prenatal examination. The basic information of pregnant women, medical and obstetric history, physical examination information, ultrasonic examination data, serum markers (PlGF, sFlt-1) test results, pre-eclampsia risk assessment results, medication history and so on were registered in the study. For high-risk pregnant women (PlGF\<100pg/ml or sFlt-1/PlGF ≥ 38), we should pay close attention to the changes of maternal blood pressure and proteinuria. Dynamic monitoring of PlGF or sFlt-1/PlGF should be carried out when necessary, and baseline information should also be registered after joining the group.

Diagnostic Test: Screening method

Interventions

Screening method DIAGNOSTIC_TEST

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

Screening based on maternal factors

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women ≥18 years old

You may qualify if:

• \) Pregnant women who have been screened for pre-eclampsia risk according to the clinical risk factors listed in NICE guidelines (2019);
• \) 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.
• \) Meet any of the above conditions, join the group voluntarily, and sign the informed consent form.

You may not qualify if:

• \) Severe fetal malformation or abnormality (no fetal heartbeat);
• \) Those who regularly use aspirin before joining the group;
• \) 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;
• \) Unable to obtain follow-up and delivery information.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

FANG HE

Guangzhou, Guangdong, 510150, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

All enrolled pregnant women will have 5 ml of peripheral blood drawn to detect PIGF levels when enrolling. Those with a high risk of preeclampsia need routine monitoring of PlGF or Soluble fms-Like Tyrosine Kinase 1（sFlt-1）/PlGF at 20-24+6 weeks and 30-30+6 weeks of pregnancy.

MeSH Terms

Conditions

Pre-Eclampsia; Maternal Death

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dunjin Chen, Professor

  The Third Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dunjin Chen, Professor

CONTACT

18928916722; gzdrchen@gzhmu.edu.cn

Fang He, M.D

CONTACT

13724831279; hefangjnu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Guangzhou Institute of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 25, 2024
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-04

Locations

CN (1)