To check for early diagnosing test for pregnancy diabetes and preterm birth

Recruiting

• Conditions: Gestational Diabetes Mellitus and Preterm birth

• Registration Number: CTRI/2018/04/013120
• Lead Sponsor: Cloudnine hospitals

Brief Summary

We plan to recruit ~300 pregnant women in early pregnancy and 50 healthy control women. Clinically confirmed pregnant women (by urine pregnancy test and/or by ultrasound scan) in 1st trimester of pregnancy (women maximum up to 3rd pregnancy), HIV negative, attending OPD of Cloudnine Care hospitals, Bangalore. Investigation methods, study protocols and patient consent forms have been approved by hospital ethics committee/IRB prior to beginning of study and enrolling the patients.

Urine and blood samples will be collected at monthly intervals along with their complete medical check up and follow-ups throughout the pregnancy. GTT will be done at 24-28 week of pregnancy. The clinical samples will be tested for presence of biomarkers in validated tests/kit mentioned above. A correlation of biomarker data with GTT, BMI, obesity, GDM, clinical outcomes, preterm births (PTB), and post natal consequences will be analysed by using appropriate statistical tools. The predictive value of the proposed biomarkers/combinations to predict GDM and propensity to preterm birth will be determined.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-03-10
• Study Start: 2018-04-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

• Recruit women >18-40 years with clinically confirmed pregnancy, status healthy, no chronic disorder, HIV negative, no diabetes at enrollment and number of pregnancy <3.
• Recruitment up to max of 12 weeks of pregnancy.
• Recruit only those who commit to stay till delivery (stable population).

Exclusion Criteria

• Women <18 years or >40 years, HIV positives & Preexisting history of diabetes.
• Those deliver outside will be excluded.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine ability and predictive value of biomarkers or combination of biomarkers to predict GDM and PTB early in first/second trimester vs GTT based diagnosis.	Outcome name: Biomarker signatures Time points : 9 months/ at the end of pregnancy

Secondary Outcome Measures

Name	Time	Method
Develop a diagnostic kit of biomarkers suitable for hospitals & point of care (POC) testing for field settings.	Outcome name : correlation of biomarkers with GTM Time points : 12 months.

Trial Locations

Locations (1)

Cloudnine Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Cloudnine Hospitals

🇮🇳Bangalore, KARNATAKA, India

Dr Kishore R kumar

Principal investigator

9900155001

drkishore@cloudninecare.com