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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.

Early pregnancy hepatic steatosis index (HSI) and metabolic profile parameters (TG/HDL-C ratio and TyG Index) in high risk pregnant women and the risk of developing adverse pregnancy outcome: A prospective cohort study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/09/057928
Enrollment
400
Registered
2023-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O099- Supervision of high risk pregnancy, unspecified

Interventions

Control Intervention1: NIL: NIL

Sponsors

JIPMER Institute Intramural Research Fund
Lead Sponsor
Dr Sasirekha R
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1) To determine the prevalence of abnormal Hepatic Steatosis Index (HSI more than 30.0) before 24 weeks of gestation 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 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 2. After the delivery of the baby

Secondary

MeasureTime frame
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 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 2. After the delivery if the baby 3. 6 weeks after the delivery if the subject had developed GDM at any point during pregnancy

Countries

India

Contacts

Public ContactPrathyusha Kode

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

drsasirekha.r_ms@ymail.com9786111445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026