A cluster randomized control trial of an Electronic Decision-Support System to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: Trial protocol

Sailesh Mohan*, Monica Chaudhry, Ona McCarthy, Prashant Jarhyan, Clara Calvert, Devraj Jindal, Rajani Shakya, Emma Radovich, Kalpana Basany, Ambuj Roy, Nikhil Tandon, Abha Shrestha, Abha Shrestha, Biraj M Karmacharya, John Cairns, Pablo Perel, Oona M. R. Campbell, Dorairaj Prabhakaran

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Background: India contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers – Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers). Methods: This will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities—one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist. Discussion: To our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries. Trial Registration. ClinicalTrials.gov, NCT03700034, registered 9 Oct 2018, https://www.clinicaltrials.gov/ct2/show/NCT03700034 CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27.

Original languageEnglish
Article number72
JournalBMC pregnancy and childbirth
Issue number1
Publication statusPublished - 26 Jan 2023

Keywords / Materials (for Non-textual outputs)

  • Anaemia in pregnancy
  • Antenatal care
  • Clinical decision-support system
  • Cluster randomized trial
  • Digital health
  • Electronic decision-support system
  • Gestational Diabetes Mellitus
  • Health system redesign
  • Maternal health services
  • Mobile health
  • Pregnancy Induced Hypertension


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