Skip to content

A Digital Tool to Help front line health providers to Detect and Manage Diabetes and High Blood Pressure During Pregnancy

Development and Evaluation of a Culturally Tailored Digital Decision Support System (DSS) for Early Screening, Medical Nutrition Therapy, and Integrated Management of GDM and HDP in Primary Care Settings in India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100281
Enrollment
1000
Registered
2026-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

None listed

Interventions

Intervention1: Digital decision support tool will be provided to front line health providers with role based modules: Rolling recruitment of 1000 consented pregnant women will be done who will be foll

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women less than or equal to 20 weeks gestation at the time of ANC registration at study PHC and CHC Willing to provide informed consent Plan to remain in the catchment area for the duration of pregnancy and postpartum.

Exclusion criteria

Exclusion criteria: Women with pre-existing diabetes or chronic hypertension diagnosed prior to pregnancy, Referred or transferred out before initial assessment Known diagnosis of diabetes mellitus prior to current screening (for pregnancy-related studies: pre-existing type 1 or type 2 diabetes). Severe comorbid illness limiting participation (e.g., advanced chronic kidney disease, severe cardiac disease). Unable to provide informed consent. Planning to move away from study area during the study period

Design outcomes

Primary

MeasureTime frame
Proportion of women diagnosed with GDM by 20 weeks gestational age using OGTTTimepoint: At baseline, midline at the time of delivery and postpartum 6 weeks and 6 months.

Secondary

MeasureTime frame
Neonatal Outcomes: Birth weight and incidence of macrosomia. Rates of NICU admission and neonatal hypoglycemiaTimepoint: At the time of delivery and postpartum 6 weeks and 6 months.;Glycemic Control Blood Pressure Control Treatment Needs and Adherence Maternal ComplicationsTimepoint: At baseline, midline at the time of delivery and postpartum 6 weeks and 6 months.;System and Provider Outcomes: Fidelity: DSS usage fidelity (percentage of prompts followed). Knowledge: Provider knowledge scores before and after training. Referrals: Appropriateness and timeliness of referrals for high-risk cases. Acceptability: Overall usability and satisfaction with the DSSTimepoint: From midline to end of the study;Qualitative Outcomes: Perceived empowerment among frontline workers (ANMs/ASHAs). User feedback on the ease of providing Medical Nutrition Therapy (MNT) and Physical Activity (PA) counselingTimepoint: Pre-intervention and post-intervention

Countries

India

Contacts

Public ContactDr Santosh Kumar Banjara

ICMR NIN, HYDERABAD

drsairamnin@gmail.com9618774603

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026