B Vitamin Deficiency and Pregnancy Complications

• Sponsor: Westlake University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05720650
• Collaborator: First People's Hospital of Hangzhou (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gestational Hypertension; Preeclampsia	Other: No intervention

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: B Vitamin Deficiency and Pregnancy Complications
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. gestational hypertension [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).

2. preeclampsia [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Westlake University
• First People's Hospital of Hangzhou

Investigators

• Principal Investigator: Hongjun SHI, PhD, Westlake University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Westlake University
• ClinicalTrials.gov Identifier: NCT05720650
• Other Study ID Numbers: WestlakeU
• First Posted: Feb 9, 2023
• Last Update Posted: Feb 9, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Westlake University: B vitamins; pregnancy complications
• Additional relevant MeSH terms: Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced; Avitaminosis

Study Results

No Results Posted as of Feb 9, 2023