Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06209411

Community Health Worker-Led Postpartum Diabetes Screening

Led by Weill Medical College of Cornell University · Updated on 2026-05-06

330

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.

CONDITIONS

Official Title

Community Health Worker-Led Postpartum Diabetes Screening

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant woman residing in one of pre-selected slum communities
  • 18 years or older
  • 24 weeks gestational age or more (based on last menstrual period or ultrasound)
  • Meets or exceeds gestational diabetes threshold by CHW-delivered fasting OGTT
  • Agrees to study procedures including postpartum in-person visits if diagnosed with gestational diabetes
  • Community Health Workers aged 18 or older willing to participate and recruit eligible women
  • CHWs reside in study communities and agree with study goals
  • Clinicians aged 18 or older with over 1 year in patient-facing diabetes or obstetrics roles
  • Ministry of Health officials aged 18 or older employed in Maternal Health Division
Not Eligible

You will not qualify if you...

  • Preexisting diabetes diagnosis before current pregnancy
  • Unable to tolerate food or drink and remain fasting for 8 hours
  • Unwilling or unable to participate in study procedures or provide informed consent
  • For CHWs, clinicians and Ministry officials: unwilling or unable to participate or consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Deep Griha Society

Pune, Maharashtra, India, 411001

Actively Recruiting

Loading map...

Research Team

J

Jyoti S Mathad, MD, MSc

CONTACT

R

Radhika Sundararajan, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here