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NCT Number: NCT06383858

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

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.

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Key information

Conditions

Preeclampsia Death Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Maternal Death Maternal Deaths Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Premature birth

    Time frame: <37 weeks

    Premature infants refer to all live births with a gestational age of<37 weeks

  2. Fetal Growth Restriction

    Time frame: 42 days after delivery

    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.

  3. Severe complications of preeclampsia

    Time frame: 42 days after delivery

    When untreated, severe complications may occur in preeclampsia, such as eclampsia, liver rupture, stroke, pulmonary edema, or renal failure,

Study contacts

Contact information is provided by the study sponsor or research team.

Dunjin Chen, Professor

CONTACT

[email protected]

18928916722

Fang He, M.D

CONTACT

[email protected]

13724831279

Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

The Project of Gestational Hypertension and Preeclampsia Screening and Prevention

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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