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NCT05632055 Clinical Trial

miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21) Profile in First Trimester and Gestational Diabetes Prediction

Gestational Diabetes Clinical Trial

Official title:
miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05632055
Other study ID # OBG-2563-07494
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 26, 2000
Est. completion date August 31, 2023

Study information
Verified date December 2022
Source ChaingMai University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups. Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.

Description:

Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited. Participants received routine standard prenatal care except, 1. additional blood test during 11-13 week 6 days (Blood was collected for further analysis) 2. performed 75gm OGTT during 24-28 week Baseline data and pregnancy outcome were reviewed.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 160
Est. completion date August 31, 2023
Est. primary completion date November 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - singleton pregnant women who attend at our clinic in first trimester Exclusion Criteria: - known underlying disease such as chronic hypertension, pregestational diabetes, SLE - normal structural fetal anatomical screening - incomplete obstetric data

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• blood draw
Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management

Locations
Country Name City State
Thailand Maharaj Nakorn ChiangMai Hospital ChiangMai

Sponsors (1)
Lead Sponsor Collaborator
ChaingMai University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary miRNA profile miRNA profile in first trimester of pregnancy and efficacy for GDM prediction within 1 month after blood drawn
Secondary FGF21 profile FGF21 profile in first trimester of pregnancy and efficacy for GDM prediction 6 months after blood drawn
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