PreeclampsiaNCT06383858
The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center
An observational study of Preeclampsia and Maternal Deaths, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Maternal Deaths
- What is being tested?
- Screening method
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women ≥18 years old
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
FANG HE
Guangzhou, Guangdong, 510150
FANG HE, M.D, 13724831279, hefangjnu@126.com
Qingwen Nie, Master, 15622149953, qw0621n@163.com
About this study
Official title: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention
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.
Read the detailed description
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.
- Conditions
- Preeclampsia, Maternal Deaths
- Being tested
- Screening method
- Keywords
- Preeclampsia, Placental growth factor (PlGF), Real-World Study, Screening, Prevention
- Medical subject headings
- Pre-Eclampsia, Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening methodDiagnostic 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 methodDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Screening method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days after delivery
Secondary outcomes (3)
Premature birth
Premature infants refer to all live births with a gestational age of<37 weeks
Measured: <37 weeks
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.
Measured: 42 days after delivery
Severe complications of preeclampsia
When untreated, severe complications may occur in preeclampsia, such as eclampsia, liver rupture, stroke, pulmonary edema, or renal failure,
Measured: 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunjin Chen, The Third Affiliated Hospital of Guangzhou Medical University
- Investigators
- Dunjin Chen, Professor, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383858
- Sponsor's protocol ID
- [2024] Ethics Review NO.114
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40948128
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Project of Gestational Hypertension and Preeclampsia Screening and Prevention
- ClinicalTrials.gov ID
- NCT06383858
- Acronym / sponsor ID
- [2024] Ethics Review NO.114
- Conditions
- Preeclampsia, Maternal Deaths
- Keywords
- Preeclampsia, Placental growth factor (PlGF), Real-World Study, Screening, Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening based on maternal factors | – | Diagnostic Test: Screening methodPregnant 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. |
| Screening based on FMF model | – | Diagnostic Test: Screening methodPreeclampsia 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women ≥18 years old
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening methodAll pregnant women in the group were screened for pre-eclampsia risk according to the clinical risk factors listed in NICE Guidelines (2019). | Diagnostic test | Screening based on maternal factors |
| Screening methodIn 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. | Diagnostic test | Screening based on FMF model |
Primary outcome
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.
3 secondary outcomes
Premature birth
Time frame: <37 weeks
Fetal Growth Restriction
Time frame: 42 days after delivery
Severe complications of preeclampsia
Time frame: 42 days after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40948128Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dunjin Chen, Professor principal investigator
The Third Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Maternal Deaths, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dunjin Chen, Professor (18928916722, gzdrchen@gzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (time frame: 42 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06383858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.