Status:
RECRUITING
Community Health Worker-Led Postpartum Diabetes Screening
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 2
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of...
Detailed Description
The purpose of the project is to determine the effectiveness of a community health worker (CHW)-delivered home based oral glucose tolerance test (OGTT) (home testing arm) versus referral for clinic-ba...
Eligibility Criteria
Inclusion
- Pregnant Women:
- Pregnant woman residing in one of pre-selected slum communities
- 18 years or older
- ≥ 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound)
- Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT
- Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM
- Community Health Workers:
- 18 years or older
- Willingness to participate in study procedures and recruit eligible pregnant women
- Agreement with goals of the study
- Resides in one of the study communities
- Willing to participate in surveys and interviews
- Clinicians:
- 18 years or older
- Diabetes or obstetrics physicians
- In a patient-facing position for over 1 year
- Ministry of Health Officials
- 18 years or older
- Employed by the Ministry of Health and Family Welfare, Maternal Health Division
Exclusion
- Pregnant Women:
- Preexisting diabetes diagnosis prior to current pregnancy
- Unable to tolerate food/ drink and remain fasting for 8 hoursUnwilling or unable to participate in study procedures
- Unwilling or unable to provide informed consent
- CHW, Clinicians, Ministry of Health Officials
- Unwilling or unable to participate in study procedures
- Unwilling or unable to provide informed consent
Key Trial Info
Start Date :
June 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06209411
Start Date
June 13 2024
End Date
October 1 2027
Last Update
May 21 2025
Active Locations (1)
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1
Deep Griha Society
Pune, Maharashtra, India, 411001