NCT05720650

Brief Summary

This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 11, 2023

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 14, 2022

Last Update Submit

April 9, 2023

Conditions

Gestational HypertensionPreeclampsia

Keywords

B vitaminspregnancy complications

Outcome Measures

Primary Outcomes (2)

  • gestational hypertension

    Gestational hypertension is diagnosed when blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine).

    seven days after delivery

  • preeclampsia

    Gestational hypertension is diagnosed when blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has positive proteinuria (excess protein in the urine).

    seven days after delivery

Study Arms (2)

Case subjects diagnosed with gestational hypertension or preeclampsia

This is a restrospective observational study and there is no intervention.

Other: No intervention

Control subjects diagnosed without any hypertensive disorders

This is a restrospective observational study and there is no intervention.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Case subjects diagnosed with gestational hypertension or preeclampsiaControl subjects diagnosed without any hypertensive disorders

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women aged 18-45 years old

You may qualify if:

  • pregnant women aged 18-40 years old

You may not qualify if:

  • women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
  • women with severe physical or mental diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

maternal blood

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-EclampsiaPregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Hongjun SHI, PhD

    Westlake University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

February 9, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 31, 2024

Last Updated

April 11, 2023

Record last verified: 2022-11

Locations

CN(1)