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Improving quality of care during childbirth in primary health centres: a stepped-wedge cluster-randomised trial in India
  1. Ramesh Agarwal1,
  2. Deepak Chawla2,
  3. Minakshi Sharma3,
  4. Shyama Nagaranjan4,
  5. Suresh K Dalpath5,
  6. Rakesh Gupta5,
  7. Saket Kumar5,
  8. Saumyadripta Chaudhuri1,
  9. Premananda Mohanty3,
  10. Mari Jeeva Sankar1,
  11. Krishna Agarwal6,
  12. Shikha Rani7,
  13. Anu Thukral1,
  14. Suksham Jain2,
  15. Chandra Prakash Yadav8,
  16. Geeta Gathwala9,
  17. Praveen Kumar10,
  18. Jyoti Sarin11,
  19. Vishnubhatla Sreenivas12,
  20. Kailash C Aggarwal13,
  21. Yogesh Kumar11,
  22. Pradip Kharya kharya14,
  23. Surender Singh Bisht15,
  24. Gopal Shridhar16,
  25. Raksha Arora17,
  26. Kapil Joshi18,
  27. Kapil Bhalla9,
  28. Aarti Soni19,
  29. Sube Singh5,
  30. Prischillal Devakirubai16,
  31. Ritu Samuel16,
  32. Reena Yadav20,
  33. Rajiv Bahl21,
  34. Vijay Kumar3,
  35. Vinod Kumar Paul1
  36. for the QI Haryana Study Collaboration
    1. 1 Division of Neonatology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
    2. 2 Department of Neonatology, Government Medical College Hospital, Chandigarh, India
    3. 3 Survival for Women and Children Foundation (SWACH), Panchkula, India
    4. 4 Saha Manthran Pvt Ltd, Gurugram, India
    5. 5 National Health Mission (Haryana), Government of India, Panchkula, India
    6. 6 Maulana Azad Medical College and LNJP Hospital, New Delhi, India
    7. 7 Department of Obstetrics and Gynecology, Government Medical College Hospital, Chandigarh, India
    8. 8 National Institute of Malaria Research, New Delhi, India
    9. 9 Pt BD Sharma PGIMS, Rohtak, India
    10. 10 PGIMER, Chandigarh, India
    11. 11 MM College of Nursing, Mullana, Ambala, India
    12. 12 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India
    13. 13 Safadarjung Hospital and Vardhman Mahavir Medical College, New Delhi, India
    14. 14 Government Medical College, Kannauj, India
    15. 15 Swami Dayanand Hospital, New Delhi, India
    16. 16 Western Command Hospital, Panchkula, India
    17. 17 Santosh Medical College, Gaziabad, India
    18. 18 UNICEF Rajasthan, Jaipur, India
    19. 19 UNICEF Chhattisgarh, Raipur, India
    20. 20 Lady Hardinge Medical College, New Delhi, India
    21. 21 WHO, Geneva, Switzerland
    1. Correspondence to Dr Vijay Kumar; 1940kumarv{at}; Professor Vinod Kumar Paul; vinodkpaul{at}


    Background Low/middle-income countries need a large-scale improvement in the quality of care (QoC) around the time of childbirth in order to reduce high maternal, fetal and neonatal mortality. However, there is a paucity of scalable models.

    Methods We conducted a stepped-wedge cluster-randomised trial in 15 primary health centres (PHC) of the state of Haryana in India to test the effectiveness of a multipronged quality management strategy comprising capacity building of providers, periodic assessments of the PHCs to identify quality gaps and undertaking improvement activities for closure of the gaps. The 21-month duration of the study was divided into seven periods (steps) of 3  months each. Starting from the second period, a set of randomly selected three PHCs (cluster) crossed over to the intervention arm for rest of the period of the study. The primary outcomes included the number of women approaching the PHCs for childbirth and 12 directly observed essential practices related to the childbirth. Outcomes were adjusted with random effect for cluster (PHC) and fixed effect for ‘months of intervention’.

    Results The intervention strategy led to increase in the number of women approaching PHCs for childbirth (26 vs 21 women per PHC-month, adjusted incidence rate ratio: 1.22; 95% CI 1.17 to 1.28). Of the 12 practices, 6 improved modestly, 2 remained near universal during both intervention and control periods, 3 did not change and 1 worsened. There was no evidence of change in mortality with a majority of deaths occurring either during referral transport or at the referral facilities.

    Conclusion A multipronged quality management strategy enhanced utilisation of services and modestly improved key practices around the time of childbirth in PHCs in India.

    Trial registration number CTRI/2016/05/006963.

    • health systems
    • maternal health
    • cluster-randomised trial
    • paediatrics

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    • Handling editor Valery Ridde

    • Collaborators We are grateful to the study coinvestigators, and the implementation and management teams, including: Mamta Jajoo, MD; Vinay Kulkarni, Neeraj Gupta, DM; Anju Huria, MS; Levis Murry, Prahlad Agarwal, Herbaksh Kaur, Amit Duggal, Jaidev Khatri, Vinod Gupta, Mangat Ram Passi, VP Mann, Alaknanda Malik, Bela Jain, VK Jain, Deepshikha Sharma.

    • Contributors Writing committee: RA, DC, VK, VKP, RB. Investigators: NHM, Haryana: RG, SK, SKD, KJ, AS, SS, AD (NHM), JK; SWACH, Chandigarh: VK, PM, MS; AIIMS, New Delhi: VKP, RA, SC, MJS, AT, VS, CPY; GMCH, Chandigarh: DC, ST, SJ; Saha Manthran, Gurugram, Haryana: SN, PA; Maulana Azad Medical College, New Delhi: KA; PGIMER, Chandigarh: PK; PGIMS, Rohtak: GG, KB; MM College of Nursing, Mullana, Ambala: JS, YK; WHO, Geneva: RB. Protocol development: VKP, VK, RB, DC, MJS. Study implementation: VK, PM, MS, Gagandeep, DS. Study resources development: SC, VKP, VK, AT, KA, RA, DC, MJS, RB. Study data team: DC. Study external facilitation team: RA, VPM, SC, SN, Shikha Taneja, KA, AT, GG, PK, JS, SJ, KCA, Yogesh Dhankar, PK, SSB, GS, RA, PD, RS, RY, KB, RB. Data analysis: MJS, RB, DC, VK, RA, VKP, CPY, VS.

    • Funding The study was funded through a grant to the WHO by USAID. The WHO team participated in the protocol development, and provided technical support to the investigators in implementation, analysis of data, interpretation of findings and preparation of the manuscript. The corresponding authors had full access to all the data in the study and bear the final responsibility for deciding about the publication.

    • Disclaimer RB is a staff member of the World Health Organization. The expressed views and opinions in this paper do not necessarily express the policies of the World Health Organization.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The institutional ethics committees of the World Health Organization, All India Institute of Medical Sciences and the Government Medical College, Chandigarh.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The deidentified dataset is available upon request.

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