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Stratification of Risk of Diabetes in Early Pregnancy

NCT03005600 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 7400

Last updated 2016-12-30

No results posted yet for this study

Summary

Hyperglycaemia in Pregnancy or Gestational Diabetes Mellitus (GDM) is one of the most common obstetric medical conditions which when undetected can cause significant adverse outcomes for the mother and the offspring. Diagnosis is typically made between 24-28 weeks of pregnancy using oral glucose tolerance test (OGTT). Therefore, some damage might have already happened prior to detection. Although universal screening is recommended by many guidelines, this is not uniformly followed across the world, partly because of doubts about cost-effectiveness. Only selective screening is followed based on presence of at least one of the high risk factors (age, BMI, previous history, etc). This strategy can miss up to 50% of GDM. In addition, no data exists in India and Kenya. In low and middle-income countries (LMICs), where majority live in rural settings, the major limitations are difficulty in conducting OGTT, which requires prompt access to laboratory facilities. Combining the clinical and easily analysable biochemical markers (composite risk score) could improve the prediction and if proven, could help to prevent the onset of GDM. Fasting glucose levels (at non-diabetes levels) in early pregnancy could predict future GDM. HbA1c in early pregnancy can be a better marker as it can be done point-of-care and does not require patients to be in a fasting state. The overall objective of the proposed project is to develop a composite risk score to predict GDM in early pregnancy using a combination of easily identifiable risk factors such as age, BMI, family history of Type 2 Diabetes along with HbA1c in Indians and Kenyans. The project will recruit pregnant women in early pregnancy from South India (n=3400) and Western Kenya (n=4000). Contribution of individual risk factors as well as the composite risk score on the risk of developing GDM will be assessed. Detailed health economic analyses will enable policy makers to make informed decision based on local data.

Conditions

  • Gestational Diabetes Mellitus

Sponsors & Collaborators

  • Madras Diabetes Research Foundation

    collaborator OTHER

  • Moi Univeristy

    collaborator OTHER

  • University of Warwick

    lead OTHER

Principal Investigators

  • Ponnusamy Saravanan, FRCP PhD · University of Warwick

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-07-31
Completion
2019-01-31

Countries

  • India
  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005600 on ClinicalTrials.gov