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Search / Trial NCT06209411

Community Health Worker-Led Postpartum Diabetes Screening

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jan 5, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Community Health Workers Type 2 Hybrid Effectiveness Implementation Trial

ClinConnect Summary

This clinical trial is focused on improving diabetes screening for women who have had gestational diabetes, which is a type of diabetes that occurs during pregnancy. Women who experience this condition are at a higher risk of developing type 2 diabetes after giving birth, especially in low-income areas like urban slums in Pune, India. The study will test whether having community health workers visit these women at home to conduct diabetes tests can help more of them get screened, as many do not receive this important follow-up care. The goal is to create a model that can be used in other similar communities to help detect diabetes early and reduce health risks for these women.

To participate in the trial, women need to be at least 18 years old, living in selected slum communities, and at least 24 weeks pregnant with a diagnosis of gestational diabetes. They will also need to agree to the study's procedures, which include visits from community health workers after they give birth. Community health workers, doctors, and health officials involved in the study must also meet certain criteria and be willing to participate. Participants can expect home visits for testing, support from health workers, and a chance to contribute to a project that aims to improve health outcomes for women in their communities.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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
  • 1. Unwilling or unable to participate in study procedures
  • 2. Unwilling or unable to provide informed consent

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

Pune, Maharashtra, India

Patients applied

0 patients applied

Trial Officials

Jyoti Mathad, MD, MSc

Principal Investigator

Weill Cornell Medicine Center for Global Health

Radhika Sundararajan, MD, PhD

Principal Investigator

Weill Cornell Medicine Center for Global Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported