NCT02276144

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 20, 2020

Status Verified

April 1, 2019

Enrollment Period

7.1 years

First QC Date

October 10, 2014

Last Update Submit

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

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

Seoul National University Hospital

Seoul, 110744, South Korea

RECRUITING

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Seoul, 156707, South Korea

RECRUITING

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.

  • Lee 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.

Biospecimen

Retention: SAMPLES WITH DNA

serum for lab tests

MeSH Terms

Conditions

Fatty LiverDiabetes, Gestational

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Joong Shin Park, MD PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JEONGEUN Kwon, MD

CONTACT

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

Locations