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

Active, not recruiting

• Conditions: Gestational Diabetes
• Interventions: Other: blood draw

• Registration Number: NCT05632055
• Lead Sponsor: Chiang Mai University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2000-08-26
• Study First Submitted: 2022-11-20
• Primary Completion: 2022-11-21
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-05
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• singleton pregnant women who attend at our clinic in first trimester

Read More

Exclusion Criteria

• known underlying disease such as chronic hypertension, pregestational diabetes, SLE
• normal structural fetal anatomical screening
• incomplete obstetric data

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancy with GDM	blood draw	Pregnant women who positive test for 100gm OGTT (abnormal 2 or more blood glucose level according NDDG (National Diabetes Data Group) criteria)
Pregnancy without GDM	blood draw	Pregnant women who negative test for 100gm OGTT

Primary Outcome Measures

Name	Time	Method
miRNA profile	within 1 month after blood drawn	miRNA profile in first trimester of pregnancy and efficacy for GDM prediction

Secondary Outcome Measures

Name	Time	Method
FGF21 profile	6 months after blood drawn	FGF21 profile in first trimester of pregnancy and efficacy for GDM prediction

Trial Locations

Locations (1)

Maharaj Nakorn ChiangMai Hospital; 🇹🇭 ChiangMai, Thailand