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Community Health Worker-delivered diabetes screening for pregnant and postpartum women in Slum Communities of Pune, India

A Type 2 Hybrid Effectiveness-Implementation Trial of Community Health Workers to Improve Screening for Postpartum Diabetes in Urban Slums of India

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053349
Enrollment
300
Registered
2023-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Community Health Worker-Delivered Home-based postpartum testing: Participants in both arms will receive CHW-delivered oral glucose tolerance testing (OGTT) during pregnancy to screen fo

Sponsors

National Institute of Child Health and Human Development (NICHD)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Referral and Home-based testing study arms 1.Pregnant woman residing in one of 12 pre-selected slum communities 2.18 years or older 3.� 24 weeks gestational age (as determined by self-reported last menstrual period or ultrasound) 4.Meet or exceed the threshold for GDM as determined by the CHW-delivered fasting OGTT 5.Agrees to study procedures, including in-person visits with the CHW postpartum if they are diagnosed with GDM CHW 1.18 years or older 2. Willingness to participate in study procedures and recruit eligible pregnant women 3. Agreement with goals of the study 4. Agreement to attend all training sessions/refresher courses 5. Willing to participate in surveys and interviews Clinicians 1.18 years or older 2. Diabetes or obstetrics physicians 3. In a patient-facing position for over 1 year Ministry of Health Officials 1.18 years or older 2.Employed by the Ministry of Health and Family Welfare, Maternal Health Division

Exclusion criteria

Exclusion criteria: Pregnant women 1.Preexisting diabetes diagnosis prior to current pregnancy 2.Unable to remain fasting for 8 hours 3.Unwilling or unable to participate in study procedures 4.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

Design outcomes

Primary

MeasureTime frame
The primary objective is to determine the effectiveness of two different CHW-delivered strategies to improve postpartum T2DM screening.Timepoint: This will be a binary outcome defined as whether the participant completed OGTT during the first year postpartum.

Secondary

MeasureTime frame
Uptake of GDM screeningTimepoint: number of participants who accept OGTT screening for GDM during enrollment;Progression to postpartum T2DM among participants with GDMTimepoint: proportion of participants who have abnormal postpartum OGTT results compared with the total number of participants with GDM in each study arm.;Optimal timing for postpartum T2DM screeningTimepoint: median time point participants complete T2DM screening within the first 12 months postpartum.;Entry in T2DM care among participants with abnormal postpartum OGTTTimepoint: percentage who complete a single clinic visit for T2DM care;Retention in T2DM careTimepoint: percentage who complete a second visit by 24 months postpartum

Countries

India

Contacts

Public ContactAshlesha Onawale

Deep Griha Society

ashlesha.onawale@yahoo.com02040187373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026