An observational study in Preeclampsia and Maternal Deaths, sponsored by The Third Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by The Third Affiliated Hospital of Guangzhou Medical University · Observational
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.
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 50,000 is above the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →The Third Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women ≥18 years old
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Screening method
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.
Diagnostic Test: Screening method
All pregnant women in the group were screened for pre-eclampsia risk according to the clinical risk factors listed in NICE Guidelines (2019).
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.
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
Premature birth
Premature infants refer to all live births with a gestational age of\<37 weeks
Time frame: <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.
Time frame: 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,
Time frame: 42 days after delivery
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The Third Affiliated Hospital of Guangzhou Medical University