The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Third Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Pregnant women ≥18 years old

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 method

    Diagnostic test

    In the first trimester, pregnant women with routine MAP and PLGF (with UtA-PI detection conditions plus UtA-PI) were tested, and the risk of preeclampsia was evaluated based on Bayes rule combined with maternal factors. In the second and third trimester of pregnancy, routine determination of PLGF or sFlt-1/PLGF was used to evaluate the risk of preeclampsia.

Treatment groups

50,000 Participants
are divided into 2 treatment groups
Group A: Screening based on maternal factors1 intervention
Group B: Screening based on FMF model1 intervention

Trial outcomes

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.

Time frame
42 days after delivery

Secondary outcomes

1

Premature birth

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

Time frame
<37 weeks
2

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.

Time frame
42 days after delivery
3

Severe complications of preeclampsia

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

Time frame
42 days after delivery

Other outcomes

Sponsors and contacts

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