Making the health system work for over 25 million births annually: drivers of the notable decline in maternal and newborn mortality in India.

INTRODUCTION: India's progress in reducing maternal and neonatal mortality since the 1990s was faster than the regional average. We systematically analysed how national health policies, services for maternal and newborn health, and socioeconomic contextual changes, drove these mortality reductions. METHODS: The study's mixed-methods design integrated quantitative trend analyses of mortality, intervention coverage and equity since the 1990s, using the sample registration system and national surveys, with interpretive understandings from policy documents and 13 key informant interviews. RESULTS: India's maternal mortality ratio (MMR) declined from 412 to 103 maternal deaths per 100 000 live births between 1997-1998 and 2017-2019. The neonatal mortality rate (NMR) declined from 46 to 22 per 1000 live births between 1997 and 2019. The average annual rate of mortality reduction increased over time. During this period, coverage of any antenatal care (57%-94%), quality antenatal care (37%-85%) and institutional delivery (34%-90%) increased, as did caesarean section rates among the poorest tertile (2%-9%); these coverage gains occurred primarily in the government (public) sector. The fastest rates for increasing coverage occurred during 2005-2012.The 2005-2012 National Rural Health Mission (which became the National Health Mission in 2012) catalysed bureaucratic innovations, additional resources, pro-poor commitments and accountability. These efforts occurred alongside smaller family sizes and improvements in macroeconomic growth, mobile and road networks, women's empowerment, and nutrition. These together reduced high-risk births and improved healthcare access, particularly among the poor. CONCLUSION: Rapid reduction in NMR and MMR in India was accompanied by increased coverage of maternal and newborn health interventions. Government programmes strengthened public sector services, thereby expanding the reach of these interventions. Simultaneously, socioeconomic and demographic shifts led to fewer high-risk births. The study's integrated methodology is relevant for generating comprehensive knowledge to advance universal health coverage.

A tale of two exemplars: the maternal and newborn mortality transitions of two state clusters in India.

BACKGROUND: India's progress in reducing maternal and newborn mortality since the 1990s has been exemplary across diverse contexts. This paper examines progress in two state clusters: higher mortality states (HMS) with lower per capita income and lower mortality states (LMS) with higher per capita income. METHODS: We characterised state clusters' progress in five characteristics of a mortality transition model (mortality levels, causes, health intervention coverage/equity, fertility and socioeconomic development) and examined health policy and systems changes. We conducted quantitative trend analyses, and qualitative document review, interviews and discussions with national and state experts. RESULTS: Both clusters reduced maternal and neonatal mortality by over two-thirds and half respectively during 2000-2018. Neonatal deaths declined in HMS most on days 3-27, and in LMS on days 0-2. From 2005 to 2018, HMS improved coverage of antenatal care with contents (ANCq), institutional delivery and postnatal care (PNC) by over three-fold. In LMS, ANCq, institutional delivery and PNC rose by 1.4-fold. C-sections among the poorest increased from 1.5% to 7.1% in HMS and 5.6% to 19.4% in LMS.Fewer high-risk births (to mothers <18 or 36+ years, birth interval <2 years, birth order 3+) contributed 15% and 6% to neonatal mortality decline in HMS and LMS, respectively. Socioeconomic development improved in both clusters between 2005 and 2021; HMS saw more rapid increases than LMS in women's literacy (1.5-fold), household electricity (by 2-fold), improved sanitation (3.2-fold) and telephone access (6-fold).India's National (Rural) Health Mission's financial and administrative flexibility allowed states to tailor health system reforms. HMS expanded public health resources and financial schemes, while LMS further improved care at hospitals and among the poorest. CONCLUSION: Two state clusters in India progressed in different mortality transitions, with efforts to maximise coverage at increasingly advanced levels of healthcare, alongside socioeconomic improvements. The transition model characterises progress and guides further advances in maternal and newborn survival.

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial.

BACKGROUND: Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. METHODS: We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. FINDINGS: Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. INTERPRETATION: The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. FUNDING: WHO, India.

Diagnostic accuracy of haemoglobin colour strip (HCS-HLL), a digital haemoglobinometer (TrueHb) and a non-invasive device (TouchHb) for screening patients with anaemia.

AIM: Estimation of haemoglobin (Hb) remains a challenge, particularly in outreach settings. There is a need to have a simple and cost-effective device to detect anaemia. Three devices (haemoglobin colour scale (HCS)-HLL (Hindustan Lifecare Limited), TrueHb V.1.1, TouchHb Alpha 1.1- non-invasive) have been developed in India recently. This study aimed to determine the diagnostic accuracy of these tests (index) for the screening of anaemia against haematological autoanalyzer (reference). METHODS: The study was conducted in four medical colleges of India. All consenting adult patients (>18 years of age) undergoing routine investigations were included. Each patient underwent the reference test and at least one index test. Outcome assessors for the index tests were blinded to the results of the reference test. Diagnostic accuracy was calculated using cut-offs proposed by WHO. RESULTS: A total of 5244 patients underwent the reference test while HCS-HLL, TrueHb and TouchHb tests were conducted on 2745, 2331 and 2874 patients respectively. The positive likelihood ratio of HCS-HLL using capillary blood (1.2), venous blood (1.7) and TouchHb (1.5) was lower than TrueHb capillary (3.7; 95% CI 3.3 to 4.2) and venous blood (5.7; 95% CI 4.9 to 6.6). TrueHb had a sensitivity of 74.4% (95% CI 71.9% to 76.8%) for venous and 82.0% (95% CI 79.8% to 89.2%) for capillary samples. The specificity was high (>75.0%). The area under receiver operating characteristic was close to 80.0%. Consistent results were seen for detection of severe anaemia. CONCLUSIONS: The digital method (TrueHb) emerged as a better diagnostic method for screening anaemia. Its effectiveness should be established in outreach settings before further recommendation.

Task shifting: A key strategy in the multipronged approach to reduce maternal mortality in India.

Task shifting from specialist to nonspecialist doctors (NSDs) is an important strategy that has been implemented in India to overcome the critical shortage of healthcare workers by using the human resources available to serve the vast population, particularly in rural areas. A competency-based training program in comprehensive emergency obstetric care was implemented to train and certify NSDs. Trained NSDs were able to provide key services in maternal health, which contribute toward reductions in maternal morbidity and mortality. The present article provides an overview of the maternal health challenges, shares important steps in program implementation, and shows how challenges can be overcome. The lessons learned from this experience contribute to understanding how task shifting can be used to address large-scale public health issues in low-resource countries and in particular solutions to address maternal health issues.

An Observational Study on the Use of IV Iron Sucrose Among Anaemic Pregnant Women in Government Healthcare Facilities from Two States of India.

BACKGROUND/PURPOSE OF THE STUDY: In India oral iron tablets for anaemia have been distributed through the health system since many years, but there has been no significant change in the burden of anaemia. The objective of the present study was to capture the existing practices on the use of intravenous iron sucrose (an alternative treatment for anaemia) in the public health system in two states of India (Tamil Nadu and Uttar Pradesh). METHODS: An observational study in the form of a registry was maintained for 3 months at purposively chosen public health facilities in the above-mentioned states of India. Anaemic pregnant women (n = 764) who were given intravenous iron sucrose during the antenatal or post-partum period were included in the registry. Information was collected on severity of anaemia at which intravenous iron sucrose therapy was initiated, the dose and schedule given and any adverse events noted during and immediate post-infusion period. RESULTS: 99 % of the infusions were given as slow infusion over a mean duration of 30 min, diluted with 0.9 % sodium chloride. The mean haemoglobin level at the time of start of intravenous therapy was 8.3 gm/dl. In Uttar Pradesh, 46 % of women received only one dose of iron sucrose in contrast with 15 % in Tamil Nadu. CONCLUSIONS: Although intravenous iron sucrose is commonly used in pregnant anaemic women, standard protocols and guidelines for its usage are lacking. These need to be formulated before scaling it up across public health facilities in India.

Every death counts: electronic tracking systems for maternal death review in India.

Maternal death review (MDR) is an important strategy to improve the quality of obstetric care and reduce maternal morbidity and mortality. MDR provides detailed information on various factors at community, facility, and district levels that influence maternal health outcomes. One of the key challenges is to analyze large volumes of data collected via a paper-based system that uses facility and community level forms. This database continues to expand quantitatively (multiple forms and data elements), which makes analysis of data increasingly difficult for timely management and analysis. The present paper describes the development process involved in linking the paper-based system with an electronic system for MDR in India. The lessons learnt from this experience can contribute to understanding how innovative technologies can be used to address large-scale public health issues in low-resource countries and in particular solutions to address maternal health.