Stratification of Risk of Diabetes in Early Pregnancy

NCT03005600 | Unknown

• 1 other identifier: MRMV0135
• Study Type: observational
• Target: 7,400
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Screening, diagnosis, risk stratification, ethnic

Outcome Measures

Primary Outcomes (1)

• Development and validation of composite risk score for GDM with the risk factors of interest and/or point-of-care HbA1c

  3 YEARS

Secondary Outcomes (1)

• Identification and the impact of other novel risk factors on the diagnosis of GDM and other adverse maternal outcomes

  3 YEARS

Study Arms (2)

Asian Indian

Recruitment to the Indian cohort will be carried out in urban areas of Chennai and be coordinated from Madras Diabetes Research Foundation (MDRF). As a part of their routine care, all pregnant women will undergo regular blood tests at presentation, a dating scan if the last menstrual period is unknown and an ultrasound at 20 weeks of pregnancy for foetal anomalies. 3400 pregnant women in early pregnancy will be studied in this cohort.

African

Recruitment to the Kenyan cohort will be based and coordinated from Moi Teaching and Referral hospital (MTRH). The bulk of the recruitment will happen at MTRH with significant contribution from Usain Gisu District hospital (UGDH) and Medi-Heal. 4000 pregnant women in early pregnancy will be studied in this cohort.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The project will be set in and around Chennai (Tamil Nadu, South India) and Eldoret (Western Kenya). Two independent cohorts will be formed, comprising of 3400 and 4000 pregnant women in early pregnancy in India and Kenya, respectively.

You may qualify if:

• All pregnant women between the age of 18 and 50 years of age

You may not qualify if:

• Women presenting beyond 16 weeks of gestation Known Type 1 or Type 2 diabetes
• Severe anaemia defined as haemoglobin (Hb) \<8g/L and
• Sickle cell traits, sickle cell anaemia and other genetic Hb variants
• Women on Metformin therapy for anovulation and/or infertility

Sponsors & Collaborators

• University of Warwick: lead
• Madras Diabetes Research Foundation: collaborator
• Moi Univeristy: collaborator

Study Sites (2)

Madras Diabetes Research Foundation

Chennai, Tamil Nadu, 600086, India

RECRUITING

Moi University School of Medicine & Teaching and Referral Hospital

Eldoret, Kenya

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Both sites have the capacity for all the necessary measurements. All samples will be temporarily stored in fridge and -20°C freezers after which it will be shifted to -80°C freezers for long term storage.

MeSH Terms

Conditions

Diabetes, Gestational; Disease

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ponnusamy Saravanan, FRCP PhD

  University of Warwick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ponnusamy Saravanan, FRCP PhD

CONTACT

00442476 153592; P.Saravanan@warwick.ac.uk

Deepa Mohan, PhD

CONTACT

00914443968888; deepa.mohan1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor & Honorary Consultant Physician

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 29, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (1); KE (1)