Risk Prediction Model of Preeclampsia

NCT04794855 | Unknown

• 1 other identifier: 76439-02
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia is the main cause of increased maternal and perinatal mortality during pregnancy. Preeclampsia is mainly manifested as hypertension, urine protein, or damage symptoms of other target organs after 20 weeks of pregnancy. In preeclampsia high-risk group, early intervention and prevention of aspirin treatment can reduce preeclampsia or reduce its complications. Some serological biomarkers, such as placental protein 13 and placental growth factor, are closely related to preeclampsia. The clinical manifestations of preeclampsia are diverse, and the biomarkers distribution of early and late preeclampsia is also different. Multivariate models will be the trend for the prediction of risk of preeclampsia. The deep learning model can train the algorithm layer by layer by unsupervised learning method, and then use the supervised back propagation algorithm for tuning. It has strong capability and flexibility, and has been successfully applied in medical fields, such as the diagnosis of skin cancer. In this study, maternal clinical data, routine laboratory indicators and biological markers in early pregnancy will be combined, and a deep learning method based on multiple models will be adopted to establish a risk prediction model for early preeclampsia, so as to improve the clinical ability for early diagnosis of preeclampsia. The deep learning method reduces the number of parameters by using spatial relative relation, which can improve the prediction ability of the model. Multi-model method is a less commonly used modeling method, and the models established by this method generally have better stability. This project combines the above two methods to establish a risk prediction model for preeclampsia, and the research is of great significance.

Conditions

Preeclampsia; Preeclampsia Severe

Keywords

Preeclampsia; deep learning; risk factors; risk prediction; biomarkers

Outcome Measures

Primary Outcomes (1)

• preeclampsia

  Pre-eclampsia is defined as new hypertension (blood pressure of 140/90 mmHg) with proteinuria (300 mg/24 h) at or after 20 gestational weeks of pregnancy

  pregnancy after 20 getational weeks

Study Arms (1)

preganant women

observation from 6-8 weeks.

Diagnostic Test: laboratory tests

Interventions

laboratory tests DIAGNOSTIC_TEST

routine laboratory tests and biomarkers tests

preganant women

Eligibility Criteria

• Age: 20 Years - 50 Years
• Gender Eligibility Details: Preeclampsia is a disease of pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

2000 cases anticipated

You may qualify if:

• Pregnant women aged 20-50 years old, primiparas or postparturas,
• and undergoing prenatal examination in Peking University Third Hospital ;
• and deliver live fetuses or stillborn fetuses with normal appearance after 24 weeks.

You may not qualify if:

• The pregant woman has tumor ,
• or has severe fetal abnormality,
• or terminates the pregnancy before 24 weeks,
• or the fetus dies.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Forestry university: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Keke Jia, master

  study director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: February 20, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: March 12, 2021

Record last verified: 2021-02

Locations

CN (1)