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

NCT ID: NCT05089175

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2024-12-30

Brief 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

Keywords

Risk prediction; Preeclampsia Prevention; Hypertensive disorders of pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women at high risk for preeclampsia

Using FIGO recommended preeclampsia screening model for the first-trimester which combined maternal risk factors, mean arterial pressure, placental growth factor, uterine artery pulsatility index to evaluate pregnant's risk for preeclampsia. Risk value≥1/100 is defined as screened high risk.

Low-dose aspirin

Intervention Type: DRUG

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.

Women at low risk for preeclampsia

Using FIGO recommended preeclampsia screening model for the first-trimester which combined maternal risk factors, mean arterial pressure, placental growth factor, uterine artery pulsatility index to evaluate pregnant's risk for preeclampsia. Risk value\<1/100 is defined as screened low risk.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baohua Li, Phd

Role: STUDY_DIRECTOR

Chief of obstetrics and gynecology

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Baohua Li, Phd

Role: CONTACT

Phone: 13777477364

Email: lbh19787@zju.edu.cn

Facility Contacts

Baohua Li, PhD

Role: primary

References

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Reference Type: BACKGROUND

PMID: 31111484 (View on PubMed)

Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

Reference Type: BACKGROUND

PMID: 28657417 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 21185591 (View on PubMed)

Navaratnam K, Alfirevic A, Jorgensen A, Alfirevic Z. Aspirin non-responsiveness in pregnant women at high-risk of pre-eclampsia. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:144-150. doi: 10.1016/j.ejogrb.2017.12.052. Epub 2018 Jan 1.

Reference Type: BACKGROUND

PMID: 29304392 (View on PubMed)

Other Identifiers

ChiCTR2100048266

Identifier Type: -

Identifier Source: org_study_id