Relationship between hepatic steatosis (accumulation of fat in the liver), blood lipid and sugar levels in high risk pregnant women early in the pregnancy and development of pregnancy related complications.
Not Applicable
- Conditions
- Health Condition 1: O099- Supervision of high risk pregnancy, unspecified
- Registration Number
- CTRI/2023/09/057928
- Lead Sponsor
- JIPMER Institute Intramural Research Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Women at least 18 years of age
2.Singleton pregnancy
3.Gestational age less than 24 weeks
4.Pregnant women with FOGSI HDP-Gestosis score (2019) of more than 2
5.Pregnant women with any one of the following risk factors for GDM:
i. Family history of Type 2 Diabetes in a first degree relative
ii. History of GDM in any one previous pregnancy
iii. History of delivering LGA baby in any one previous pregnancy (more than 90th centile)
Exclusion Criteria
1.Women with chronic hypertension
2.Pregestational diabetes
3.BMI more than 40kg/m2
4.Fetus with major congenital anomalies
5.Known pre-existing liver/ biliary tract dis-orders
6.Chronic Renal diseases
7.Known connective tissue diseases
8.Mental disorders
9.Thromboembolic disease prior to pregnancy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) To determine the prevalence of abnormal Hepatic Steatosis Index (HSI more than 30.0) before 24 weeks of gestation <br/ ><br>2) To assess the association of early pregnancy abnormal HSI (more than 30.0) with the subsequent development of adverse pregnancy outcome (GDM, Pre-eclampsia (PE), Preterm births (PTB) & delivering large for gestational age (LGA) babies) in current pregnancy <br/ ><br>3) To study the prevalence of abnormal metabolic parameters like fasting triglyceride/high density lipoprotein cholesterol ratio (TG/HDL-C), ratio) & fasting triglyceride glucose (TyG) index among women with abnormal HSITimepoint: 1. When gestational age of subject less than 24 weeks <br/ ><br>2. After the delivery of the baby
- Secondary Outcome Measures
Name Time Method 1) To evaluate the association between abnormal metabolic parameters (TG/HDL-C ratio & TyG index) before 24 weeks and subsequent development of adverse pregnancy outcome (GDM, PE, PTB and delivering LGA babies) in current pregnancy <br/ ><br>2) To compare of the prevalence of persistent abnormal glycemic profile after 6 weeks post-partum (abnormal fasting blood sugars (FBS) and HbA1c) among women who developed GDM with normal HSI and abnormal HSI during early pregnancyTimepoint: 1. When gestational age of the subject less than 24 weeks <br/ ><br>2. After the delivery if the baby <br/ ><br>3. 6 weeks after the delivery if the subject had developed GDM at any point during pregnancy