NCT05134285

Brief Summary

The purpose of this study is to evaluate the risk factors of recurrent preeclampsia and compare the short-term and long-term adverse outcomes of women and their offspring.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.8 years

First QC Date

November 8, 2021

Last Update Submit

December 7, 2021

Conditions

PreeclampsiaRecurrenceHypertension

Outcome Measures

Primary Outcomes (18)

  • blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    1year after the second deliver

  • blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    3 years after the second deliver

  • blood pressure and hypertension of women

    blood pressure ≥140/90 mmHg

    5 years after the second deliver

  • blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    1 year old

  • blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    3 years old

  • blood pressure and hypertension of offspring

    blood pressure≥140/90 mmHg

    5 years old

  • level of glycosylated hemoglobin in blood

    women

    1 year after the second deliver

  • level of glycosylated hemoglobin in blood

    women

    3 years after the second deliver

  • level of glycosylated hemoglobin in blood

    women

    5 years after the second deliver

  • level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    1 year after the second deliver

  • level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    3 years after the second deliver

  • level of cholesterol, LDL, HDL, VLDL-C in blood

    women

    5 years after the second deliver

  • level of FT3,FT4, and hTSH in blood

    women

    1year after the second deliver

  • level of FT3,FT4, and hTSH in blood

    women

    3 years after the second deliver

  • level of FT3,FT4, and hTSH in blood

    women

    5 years after the second deliver

  • level of AST and ALT in blood

    women

    1year after the second deliver

  • level of AST and ALT in blood

    women

    3 years after the second deliver

  • level of AST and ALT in blood

    women

    5 years after the second deliver

Secondary Outcomes (12)

  • BMI of offspring

    1 year old

  • BMI of offspring

    3 years old

  • BMI of offspring

    5 years old

  • level of insulin in blood

    1year after the second deliver

  • level of insulin in blood

    3 years after the second deliver

  • +7 more secondary outcomes

Study Arms (3)

control

pregnancy without preeclampsia

Other: blood pressure,BMI, blood sample

preeclampsia

pregnancy complicated with preeclampsia at the first delivery or at the second delivery

Other: blood pressure,BMI, blood sample

recurrent preeclampsia

pregnancy complicated with preeclampsia at two deliveries

Other: blood pressure,BMI, blood sample

Interventions

blood pressure,BMI, blood sampleOTHER

Blood pressure will be monitored. BMI will be measured. Blood samples will be tested.

controlpreeclampsiarecurrent preeclampsia

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women with at least twice of delivery history are divided into three groups, control group refers to women without preeclampsia history, the second group refers to women complicated with preeclampsia at the first delivery or at the second delivery, the third group refers to women complicated with preeclampsia at two deliveries.

You may qualify if:

  • women with at least twice of delivery history

You may not qualify if:

  • women with chronic hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510150, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Pre-EclampsiaRecurrenceHypertension

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Dunjin Chen

CONTACT

18928916722gzdrchen@gzhmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 24, 2021

Study Start

January 1, 2022

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

December 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)