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Clinical Trials/NCT06383858
NCT06383858
Recruiting
Not Applicable

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention

The Third Affiliated Hospital of Guangzhou Medical University1 site in 1 country50,000 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preeclampsia
Sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Enrollment
50000
Locations
1
Primary Endpoint
Preeclampsia
Status
Recruiting
Last Updated
2 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
December 31, 2028
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Dunjin Chen

Director of Guangzhou Institute of Obstetrics and Gynecology

The Third Affiliated Hospital of Guangzhou Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Preeclampsia

Time Frame: 42 days after delivery

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.

Secondary Outcomes

  • Premature birth(<37 weeks)
  • Fetal Growth Restriction(42 days after delivery)
  • Severe complications of preeclampsia(42 days after delivery)

Study Sites (1)

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