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      Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial

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          Abstract

          Background

          Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale.

          Methods/design

          This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer “coach” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility.

          Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size ( n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births ( n = 6000).

          The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers.

          Discussion

          If effective, the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries.

          Trial registration

          BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-016-1673-x) contains supplementary material, which is available to authorized users.

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          Most cited references18

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          Maternal near miss--towards a standard tool for monitoring quality of maternal health care.

          Maternal mortality is still among the worst performing health indicators in resource-poor settings. For deaths occurring in health facilities, it is crucial to understand the processes of obstetric care in order to address any identified weakness or failure within the system and take corrective action. However, although a significant public health problem, maternal deaths are rare in absolute numbers especially within an individual facility. Studying cases of women who nearly died but survived a complication during pregnancy, childbirth or postpartum (maternal near miss or severe acute maternal morbidity) are increasingly recognized as useful means to examine quality of obstetric care. Nevertheless, routine implementation and wider application of this concept in reviewing clinical care has been limited due to the lack of a standard definition and uniform case-identification criteria. WHO has initiated a process in agreeing on a definition and developing a uniform set of identification criteria for maternal near miss cases aiming to facilitate the reviews of these cases for monitoring and improving quality of obstetric care. A list of identification criteria was proposed together with one single definition. This article presents the proposed definition and the identification criteria of maternal near miss cases. It also suggests procedures to make maternal near miss audits operational in monitoring/evaluating quality of obstetric care. The practical implementation of maternal near miss concept should provide an important contribution to improving quality of obstetric care to reduce maternal deaths and improve maternal health.
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            India's Janani Suraksha Yojana, a conditional cash transfer programme to increase births in health facilities: an impact evaluation.

            In 2005, with the goal of reducing the numbers of maternal and neonatal deaths, the Government of India launched Janani Suraksha Yojana (JSY), a conditional cash transfer scheme, to incentivise women to give birth in a health facility. We independently assessed the effect of JSY on intervention coverage and health outcomes. We used data from the nationwide district-level household surveys done in 2002-04 and 2007-09 to assess receipt of financial assistance from JSY as a function of socioeconomic and demographic characteristics; and used three analytical approaches (matching, with-versus-without comparison, and differences in differences) to assess the effect of JSY on antenatal care, in-facility births, and perinatal, neonatal, and maternal deaths. Implementation of JSY in 2007-08 was highly variable by state-from less than 5% to 44% of women giving birth receiving cash payments from JSY. The poorest and least educated women did not always have the highest odds of receiving JSY payments. JSY had a significant effect on increasing antenatal care and in-facility births. In the matching analysis, JSY payment was associated with a reduction of 3.7 (95% CI 2.2-5.2) perinatal deaths per 1000 pregnancies and 2.3 (0.9-3.7) neonatal deaths per 1000 livebirths. In the with-versus-without comparison, the reductions were 4.1 (2.5-5.7) perinatal deaths per 1000 pregnancies and 2.4 (0.7-4.1) neonatal deaths per 1000 livebirths. The findings of this assessment are encouraging, but they also emphasise the need for improved targeting of the poorest women and attention to quality of obstetric care in health facilities. Continued independent monitoring and evaluations are important to measure the effect of JSY as financial and political commitment to the programme intensifies. Bill & Melinda Gates Foundation. Copyright 2010 Elsevier Ltd. All rights reserved.
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              WHO systematic review of maternal morbidity and mortality: the prevalence of severe acute maternal morbidity (near miss)

              Aim To determine the prevalence of severe acute maternal morbidity (SAMM) worldwide (near miss). Method Systematic review of all available data. The methodology followed a pre-defined protocol, an extensive search strategy of 10 electronic databases as well as other sources. Articles were evaluated according to specified inclusion criteria. Data were extracted using data extraction instrument which collects additional information on the quality of reporting including definitions and identification of cases. Data were entered into a specially constructed database and tabulated using SAS statistical management and analysis software. Results A total of 30 studies are included in the systematic review. Designs are mainly cross-sectional and 24 were conducted in hospital settings, mostly teaching hospitals. Fourteen studies report on a defined SAMM condition while the remainder use a response to an event such as admission to intensive care unit as a proxy for SAMM. Criteria for identification of cases vary widely across studies. Prevalences vary between 0.80% – 8.23% in studies that use disease-specific criteria while the range is 0.38% – 1.09% in the group that use organ-system based criteria and included unselected group of women. Rates are within the range of 0.01% and 2.99% in studies using management-based criteria. It is not possible to pool data together to provide summary estimates or comparisons between different settings due to variations in case-identification criteria. Nevertheless, there seems to be an inverse trend in prevalence with development status of a country. Conclusion There is a clear need to set uniform criteria to classify patients as SAMM. This standardisation could be made for similar settings separately. An organ-system dysfunction/failure approach is the most epidemiologically sound as it is least open to bias, and thus could permit developing summary estimates.
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                Author and article information

                Contributors
                ksemrau@ariadnelabs.org
                lhirschhorn@ariadnelabs.org
                drkodkany@jnmc.edu
                spectorjm@gmail.com
                dtuller@ariadnelabs.org
                King@harvard.edu
                slipsitz@partners.org
                narendersharma@psi.org.in
                vpsingh@psi.org.in
                bharath.kotta@gmail.com
                dhingran@who.int
                rfirestone@psi.org
                vishwajeet.kumar@shivgarh.org
                agawande@partners.org
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                7 December 2016
                7 December 2016
                2016
                : 17
                : 576
                Affiliations
                [1 ]Ariadne Labs/Harvard Medical School, 401 Park Drive, 3rd floor East, Boston, MA 02115 USA
                [2 ]JNMC Medical College, Belgaum, 590010 Karnataka India
                [3 ]Novartis Institutes for BioMedical Research, 250 Massachusetts Avenue, Cambridge, MA 02138 USA
                [4 ]Ariadne Labs/Harvard T.H. Chan School of Public Health, 401 Park Drive, 3rd floor East, Boston, MA 02115 USA
                [5 ]Harvard University, 1737 Cambridge Street Harvard University, Cambridge, MA 02138 USA
                [6 ]Brigham and Women’s Hospital, 1620 Tremont Street, 4-020, Boston, MA 02120 USA
                [7 ]Population Services International, 2/325, Vijayant Khand, Gomti Nagar, Lucknow, 226010 Uttar Pradesh India
                [8 ]World Health Organization, 20, Avenue Appia, 1211, Geneva 27, Switzerland
                [9 ]Population Services International, 1120 19th Street, NW, Suite 600, Washington, DC 20036 USA
                [10 ]Community Empowerment Lab, 26/11 Wazeer Hassan Road, Lucknow, 226001 India
                [11 ]Ariadne Labs/Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115 USA
                Article
                1673
                10.1186/s13063-016-1673-x
                5142140
                27923401
                e33d1a4d-4035-4603-a28c-58bd50270c50
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 15 May 2016
                : 26 October 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award ID: OPP 1017378
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                cluster-randomized controlled trial,who safe childbirth checklist,maternal health,newborn health,perinatal health,stillbirth,coaching,supportive supervision,quality improvement,india

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