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
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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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