B Vitamin Deficiency and Pregnancy Complications

April 9, 2023 updated by: Westlake University
This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In clinical practice, women diagnosed with gestational hypertension or preeclampsia will be asked to participate this study to fill a questionnaire reporting their basic information. Meanwhile, women with matched age and gestation week and without any kinds of hypertensive disorders will also be invited for this study. Participants' blood samples will be analyzed for B vitamin levels at the end of the study.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

pregnant women aged 18-45 years old

Description

Inclusion Criteria:

  • pregnant women aged 18-40 years old

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case subjects diagnosed with gestational hypertension or preeclampsia
This is a restrospective observational study and there is no intervention.
Other: No intervention
No intervention
Control subjects diagnosed without any hypertensive disorders
This is a restrospective observational study and there is no intervention.
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestational hypertension
Time Frame: seven days after delivery
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
Time Frame: seven days after delivery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Westlake University

Collaborators

First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestlakeU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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