NCT05089175

The Investigation of the Prediction Model and Prevention Strategy of Serious Pregnancy Complications in Hypertensive Disorders of Pregnancy Based on the Chinese Population

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,500 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

1\. Evaluation of the efficacy of aspirin in preventing preeclampsia and its serious complications during pregnancy and postpartum. 2. To establish a risk prediction model for severe pregnancy complications in pregnant women with hypertensive disorders of pregnancy.

Detailed description

Hypertensive disorders of pregnancy (HDP) is the second leading cause of maternal death in clinical practice. The prediction and prevention of HDP and its serious complications could be a breakthrough to further reduce the maternal mortality rate in China. Aspirin (ASP) is widely used clinically as a first-line prevention program for preeclampsia (PE). However, how to determine the effectiveness of ASP prevention before the onset of PE high-risk pregnant women and adjust the risk monitoring plan accordingly has become a clinical difficult point. Two prospective and observational researches will be lauched in this study. In the first part of this study, ASP resistance test and HDP-related biomarkers will be combined to evaluate the effect of ASP on the prevention of PE from multiple dimensions, and placental pathology will be analyzed to assist evaluate, in order to more comprehensively evaluate the preventive effect of aspirin in high-risk of PE pregnant women in the first and second trimester. In the second part of this study, we aim to reduce the incidence of serious HDP complications and improve maternal and child outcomes for pregnant women with HDP who have missed HDP prediction and prevention opportunities in the first trimester, or aspirin prevention is ineffective. It is planned to establish a risk prediction model for severe pregnancy complications in pregnant women with HDP by adding other biological and physical indicators on the basis of maternal factors, in order to more accurately predict one or several severe complications of HDP over a period of time.

Conditions

• Hypertensive Disorder of Pregnancy
• Pregnancy Complications

Interventions

Type	Name	Description
DRUG	Low-dose aspirin	FIGO adopts and supports that in high-risk women, defined by the first-trimester combined test, aspirin \~150 mg/night should be commenced at 11-14+6 weeks of gestation until either 36 weeks of gestation, when delivery occurs, or when pre-eclampsia is diagnosed.

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2021-10-22
• Last updated: 2021-12-02

Locations

1 site across 1 country: China