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

Development of a Bio marker based test for Prediction of Gestational Diabetes Mellitus(GDM) and Preterm birth (PTB) - GDM and PTB

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/04/013120
Enrollment
350
Registered
2018-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

None listed

Sponsors

Cloudnine hospitals
Lead Sponsor
Foundation for Neglected Diseases Research FNDR
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria: Women 40 years, HIV positives & Preexisting history of diabetes. Those deliver outside will be excluded.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Outcome name: Biomarker signatures Time points : 9 months/ at the end of pregnancy—

Secondary

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

Countries

India

Contacts

Public ContactDr Kishore R Kumar

Kids Clinic India private limited(Cloudnine Hospitals)

drkishore@cloudninecare.com9900155001

Outcome results

None listed

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