Gestational HypertensionNCT05720650
B Vitamin Deficiency and Pregnancy Complications
An observational study of Gestational Hypertension and Preeclampsia, run by Westlake University at 1 site in China.
Trial summary
This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension, Preeclampsia
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women aged 18-45 years old
Who may be able to join
- pregnant women aged 18-40 years old
Who cannot join
- women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- women with severe physical or mental diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.
Read the 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.
- Conditions
- Gestational Hypertension, Preeclampsia
- Being tested
- No intervention
- Keywords
- B vitamins, pregnancy complications
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Case subjects diagnosed with gestational hypertension or preeclampsia | This is a restrospective observational study and there is no intervention. Receives: Other: No intervention | |
| Control subjects diagnosed without any hypertensive disorders | This is a restrospective observational study and there is no intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: seven days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: plans changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Hongjun SHI, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720650
- Sponsor's protocol ID
- WestlakeU
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B Vitamin Deficiency and Pregnancy Complications
- ClinicalTrials.gov ID
- NCT05720650
- Acronym / sponsor ID
- WestlakeU
- Conditions
- Gestational Hypertension, Preeclampsia
- Keywords
- B vitamins, pregnancy complications
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: plans changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- First People's Hospital of Hangzhou
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case-control study aims to investigate the association between B vitamins and gestational hypertension or preeclampsia.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case subjects diagnosed with gestational hypertension or preeclampsia | – | Other: No interventionThis is a restrospective observational study and there is no intervention. |
| Control subjects diagnosed without any hypertensive disorders | – | Other: No interventionThis is a restrospective observational study and there is no intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women aged 18-45 years old
Key inclusion criteria (1 listed)
- pregnant women aged 18-40 years old
Key exclusion criteria (2 listed)
- women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
- women with severe physical or mental diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Case subjects diagnosed with gestational hypertension or preeclampsia, Control subjects diagnosed without any hypertensive disorders |
Primary outcome
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).
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gestational Hypertension
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongjun SHI, PhD principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Hypertension and Preeclampsia, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gestational hypertension (time frame: seven days after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.