The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

Preeclampsia Clinical Trial

Official title:

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383858
• Other study ID #: [2023] Ethics Review NO.151
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: Dunjin Chen, Professor
• Phone: 18928916722
• Email: gzdrchen[@]gzhmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Maternal Death
• Maternal Deaths
• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
China	FANG HE	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Premature birth	Premature infants refer to all live births with a gestational age of<37 weeks	<37 weeks
Secondary	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
Secondary	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