Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
Investigation on the Frequency and Obstetric Significance of Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy
1 other identifier
observational
2,400
1 country
3
Brief Summary
The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
3 active sites
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
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 28, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMarch 20, 2020
April 1, 2019
7.1 years
October 10, 2014
March 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Compare prevalence of obstetric complications between non-alcoholic fatty liver and normal pregnant women
Obstetrical complications include gestational diabetes, preeclampsia, etc Non-alcoholic fatty liver diagnosed by using liver ultrasound result of 1st trimester and blood test (AST, APT)
From date of enrollment until the date of delivery, assessed up to 35wks
Interventions
For evaluate whether fatty liver is exist or not
Eligibility Criteria
1st trimester pregnancy women with singleton
You may qualify if:
- Outpatient clinic patients of Seoul National University Hospital, Seoul Metropolitan Government Boramae Medical Center, Incheon Seoul Woman Hospital
- Agree with this study
- Do not drink excess amount of alcohol for recent 2 years
You may not qualify if:
- Do not agree with this study
- Do not perform blood tests
- Have underlying hepatobiliary diseases
- Take medications which can cause liver abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Seoul Women's Hospital
Incheon, 402859, South Korea
Seoul National University Hospital
Seoul, 110744, South Korea
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
Seoul, 156707, South Korea
Related Publications (2)
Zhang J, Suo Y, Wang L, Liu D, Jia Y, Fu Y, Fan W, Jiang Y. Association between atherogenic index of plasma and gestational diabetes mellitus: a prospective cohort study based on the Korean population. Cardiovasc Diabetol. 2024 Jul 5;23(1):237. doi: 10.1186/s12933-024-02341-9.
PMID: 38970008DERIVEDLee SM, Hwangbo S, Norwitz ER, Koo JN, Oh IH, Choi ES, Jung YM, Kim SM, Kim BJ, Kim SY, Kim GM, Kim W, Joo SK, Shin S, Park CW, Park T, Park JS. Nonalcoholic fatty liver disease and early prediction of gestational diabetes mellitus using machine learning methods. Clin Mol Hepatol. 2022 Jan;28(1):105-116. doi: 10.3350/cmh.2021.0174. Epub 2021 Oct 15.
PMID: 34649307DERIVED
Biospecimen
serum for lab tests
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joong Shin Park, MD PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 28, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
March 20, 2020
Record last verified: 2019-04