RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Impact of a school-based nutrition educational intervention on knowledge related to iron deficiency anaemia in rural Karnataka, India: A mixed methods pre-post interventional study.

OBJECTIVE: To understand the extent to which adolescent awareness about anaemia and anaemia prevention can be changed by nutrition messages received at school. DESIGN: Mixed-methods pre-post intervention study. SETTING: Three government schools in Bagalkot, Belagavi and Raichur districts of Karnataka, India. POPULATION: Students of grade six and seven and teachers involved in implementing the intervention. METHODS: An educational intervention was co-developed by school teachers and nutrition experts using locally adapted resource materials that consisted of lectures, role play and practical demonstrations. Seven half-hour educational sessions were delivered by school teachers over 7 weeks to 455 students. Pre- and post-intervention tests measured changes in adolescents' knowledge about anaemia. Semi-structured in-depth interviews with teachers and focus groups with students explored their reactions to the intervention. MAIN OUTCOME MEASURES: Knowledge score related to anaemia. RESULTS: The percentage of children with correct scores increased by 7.3-49.0 percentage points for the tested questions after implementation of the intervention. The mean knowledge score increased by 3.67 ± 0.17 (p < 0.01). During interviews, teachers and students highlighted high acceptance of the intervention and materials, an increase in awareness, a positive attitude towards changing behaviour around diet, an increase in the demand for iron and folic acid supplements and improved sharing of messages learned with peers and families. Challenges expressed included need for further training, time limitations and hesitancy in teaching about menstruation and pregnancy. CONCLUSIONS: Educational interventions carried out for adolescents by teachers in schools are effective in improving awareness and attitude related to anaemia and its prevention.

Attention for and awareness of anemia in adolescents in Karnataka, India: A qualitative study.

Between 1990 and 2016 the number of adolescents with anemia world-wide increased by 20% to almost one in four. Iron deficiency in adolescence results in compromised growth, decreased cognitive function, and depressed immune function, and can increase the risk of negative outcomes in pregnancy, especially in the case of young adolescents. In India, despite several decades of governmental investment in anemia prevention and treatment, more than half of women of reproductive age are anemic, with rates even higher in the adolescent population. Although awareness of adolescence as a nutrition-sensitive developmental stage is increasing, there is a lack of qualitative research on the perspectives of adolescents and families on anemia and related services. In this study, we explored the issues influencing adolescents' awareness of anemia in three rural areas of Karnataka. Sixty-four in-depth interviews and six focus group discussions were conducted with adolescents (those who had never been pregnant, pregnant adolescents, and young mothers), community members, and nutrition-related service providers in the health and education sectors. An inductive analytical approach was used. We found that adolescent girls, particularly those who have not experienced pregnancy or motherhood, had very low awareness of anemia. State programs including school-based distribution of iron and folic acid supplements and nutrition talks were not seen to be resulting in knowledge and acceptance of the importance of preventing anemia. Pregnancy represents a turning point in which adolescents are systematically tested for anemia as part of routine antenatal care, increasing their awareness of, and access to, treatment for the condition. At the same time, pregnancy represents to family and community a period to insist on a nutritious diet. For progress in anemia reduction to be made, improved age-appropriate measures specific for adolescence are required. Improving school-based nutrition outreach is an important opportunity to reach adolescents.

Anemia and adverse outcomes in pregnancy: subgroup analysis of the CLIP cluster-randomized trial in India.

BACKGROUND: Iron-deficiency anemia is a known risk factor for several adverse perinatal outcomes, but data on its impact on specific maternal morbidities is less robust. Further, information on associations between anemia in early pregnancy and subsequent outcomes are understudied. METHODS: The study population was derived from the Community Level Interventions for Pre-eclampsia (CLIP) trial in Karnataka State, India (NCT01911494). Included were women who were enrolled in either trial arm, delivered by trial end date, and had a baseline measure of hemoglobin (Hb). Anemia was classified by WHO standards into four groups: none (Hb ≥ 11 g/dL), mild (10.0 g/dL ≤ Hb < 11.0 g/dL), moderate (7.0 g/dL ≤ Hb < 10.0 g/dL) and severe (Hb < 7.0 g/dL). Targeted maximum likelihood estimation was used to estimate confounder-adjusted associations between anemia and a composite (and its components) of adverse maternal outcomes, including pregnancy hypertension. E-values were calculated to assess robustness to unmeasured confounding. RESULTS: Of 11,370 women included, 10,066 (88.5%) had anemia, that was mild (3690, 32.5%), moderate (6023, 53.0%), or severe (68, 0.6%). Almost all women (> 99%) reported taking iron supplements during pregnancy. Blood transfusions was more often administered to those with anemia that was mild (risk ratio [RR] 2.16, 95% confidence interval [CI] 1.31-3.56), moderate (RR 2.37, 95% CI 1.56-3.59), and severe (RR 5.70, 95% CI 3.00-10.85). No significant association was evident between anemia severity and haemorrhage (antepartum or postpartum) or sepsis, but there was a U-shaped association between anemia severity and pregnancy hypertension and pre-eclampsia specifically, with the lowest risk seen among those with mild or moderate anemia. CONCLUSION: In Karnataka State, India, current management strategies for mild-moderate anemia in early pregnancy are associated with similar rates of adverse maternal or perinatal outcomes, and a lower risk of pregnancy hypertension and preeclampsia, compared with no anemia in early pregnancy. Future research should focus on risk mitigation for women with severe anemia, and the potential effect of iron supplementation for women with normal Hb in early pregnancy.

Community engagement for birth preparedness and complication readiness in the Community Level Interventions for Pre-eclampsia (CLIP) Trial in India: a mixed-method evaluation.

OBJECTIVE: To describe the process of community engagement (CE) in northern Karnataka, India and its impact on pre-eclampsia knowledge, birth preparedness and complication readiness, pregnancy-related care seeking and maternal morbidity. DESIGN: This study was a secondary analysis of a cluster randomised trial of Community Level Interventions for Pre-eclampsia (CLIP). A total of 12 clusters based on primary health centre catchment areas were randomised to intervention or control. CE was conducted in intervention clusters. CE attendance was summarised according to participant group using both quantitative and qualitative assessment. Pre-eclampsia knowledge, birth preparedness, health services engagement and perinatal outcomes was evaluated within trial surveillance. Outcomes were compared between trial arms using a mixed effects logistic regression model on RStudio (RStudio, Boston, USA). Community feedback notes were thematically analysed on NVivo V.12 (QSR International, Melbourne, Australia). SETTING: Belagavi and Bagalkote districts in rural Karnataka, India. PARTICIPANTS: Pregnant women and women of reproductive age, mothers and mothers-in-law, community stakeholders and male household decision-makers and health workers. RESULTS: A total of 1379 CE meetings were conducted with 39 362 participants between November 2014 and October 2016. CE activities may have had an effect on modifying community attitudes towards hypertension in pregnancy and its complications. However, rates of pre-eclampsia knowledge, birth preparedness, health services engagement and maternal morbidities among individual pregnant women were not significantly impacted by CE activities in their area. CONCLUSION: Evaluation of our CE programme in India demonstrates the feasibility of reaching pregnant women alongside household decision-makers, community stakeholders and health workers. More research is needed to explore the pathways of impact between broad community mobilisation to strengthen support for maternal care seeking and clinical outcomes of individual pregnant women. TRIAL REGISTRATION NUMBER: NCT01911494.

Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India.

Introduction: PIERS on the Move (POM) is a mobile health (mHealth) application developed for a smartphone to support community health workers (CHWs) for identification and management of women at risk of adverse outcomes from pre-eclampsia. POM was implemented as an addition to routine antenatal care by accredited social health activists (ASHAs) and auxiliary nurse midwives (ANMs) during the community level intervention for pre-eclampsia (CLIP) Trial in Karnataka state, India (NCT01911494). The objective of this study was to evaluate the experiences of CHWs of using POM in rural India and their perceptions of acceptability and feasibility of this mHealth intervention. Methods: A posttrial mixed-methods evaluation was designed to measure CHW knowledge and self-efficacy regarding the care of women with pre-eclampsia and perceptions of CHWs on the ease of use and usefulness of POM. A structured survey with open-ended questions was conducted between October and November 2017. The median values on a 5-point Likert scale for knowledge and self-efficacy questions were compared between trial arms by Mann-Whitney U test (p < 0.05 significant). Qualitative analysis was undertaken on NVivo 12 (QSR International, Melbourne, Australia). Results: A total of 48 ASHAs and ANMs were interviewed, including 24 who used POM (intervention arm) and 24 who did not (control arm). Self-reported knowledge and self-efficacy for the care of women with pre-eclampsia did not differ between groups. The qualitative analysis highlighted that health workers who used POM reported improved interactions with women and families in their communities. POM strengthened the role of ASHA as a CHW beyond a "link-worker" accompanying women to health services. With training, the mHealth application was easy to use even for CHWs who did not have much experience with smartphones. Conclusions: Community health workers found the POM app easy to use, useful, and well-received by women and their families. POM did not improve care through increased knowledge but built capacity by increasing the recognition of the ASHA and ANM as critical members of the continuum of antenatal healthcare within their communities. These findings support the important role that mHealth technologies can play in strengthening health systems to reach rural, remote, and marginalized populations to reduce disparities in health.

Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting.

BACKGROUND: Neonatal mortality causes a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC). METHODS: We undertook a prospective, population-based research study of pregnant women residing in defined geographic areas in the Karnataka State of India, a research site of the Global Network for Women's and Children's Health Research. Study staff collected demographic and health care characteristics on eligible women enrolled with neonatal outcomes obtained at delivery and day 28. Cause of neonatal mortality at day 28 was assigned by algorithm using prospectively defined variables. RESULTS: From 2014 to 2018, the neonatal mortality rate was 24.5 per 1,000 live births. The cause of the 28-day neonatal deaths was attributed to prematurity (27.9%), birth asphyxia (25.1%), infection (23.7%) and congenital anomalies (18.4%). Four or more antenatal care (ANC) visits was associated with a lower risk of neonatal death compared to fewer ANC visits. In the adjusted model, compared to liveborn infants ≥ 2500 g, infants born weighing < 1000 g RR for mortality was 25.6 (95%CI 18.3, 36.0), for 1000-1499 g infants the RR was 19.8 (95% CI 14.2, 27.5) and for 1500-2499 g infants the RR was 3.1 (95% CI 2.7, 3.6). However, more than one-third (36.8%) of the deaths occurred among infants with a birthweight ≥ 2500 g. Infants born preterm (< 37 weeks) were also at higher risk for 28-day mortality (RR 7.9, 95% CI 6.9, 9.0) compared to infants ≥ 37 weeks. A one-week decrease in gestational age at delivery was associated with a higher risk of mortality with a RR of 1.3 (95% CI 1.3, 1.3). More than 70% of all the deliveries occurred at a hospital. Among infants who died, 50.3% of the infants had received bag/mask ventilation, 47.3% received antibiotics, and 55.6% received oxygen. CONCLUSIONS: Consistent with prior research, the study found that infants who were preterm and low-birth weight remained at highest risk for 28-day neonatal mortality in India. Although most of births now occur within health facilities, a substantial proportion are not receiving basic life-saving interventions. Further efforts to understand the impact of care on infant outcomes are needed. Study registration The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475.

The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries.

BACKGROUND: Due to high fertility rates in some low and lower-middle income countries, the interval between pregnancies can be short, which may lead to adverse maternal and neonatal outcomes. METHODS: We analyzed data from women enrolled in the NICHD Global Network Maternal Newborn Health Registry (MNHR) from 2013 through 2018. We report maternal characteristics and outcomes in relationship to the inter-delivery interval (IDI, time from previous delivery [live or stillborn] to the delivery of the index birth), by category of 6-17 months (short), 18-36 months (reference), 37-60 months, and 61-180 months (long). We used non-parametric tests for maternal characteristics, and multivariable logistic regression models for outcomes, controlling for differences in baseline characteristics. RESULTS: We evaluated 181,782 women from sites in the Democratic Republic of Congo, Zambia, Kenya, Guatemala, India, and Pakistan. Women with short IDI varied by site, from 3% in the Zambia site to 20% in the Pakistan site. Relative to a 18-36 month IDI, women with short IDI had increased risk of neonatal death (RR = 1.89 [1.74, 2.05]), stillbirth (RR = 1.70 [1.56, 1.86]), low birth weight (RR = 1.38 [1.32, 1.44]), and very low birth weight (RR = 2.35 [2.10, 2.62]). Relative to a 18-36 month IDI, women with IDI of 37-60 months had an increased risk of maternal death (RR 1.40 [1.05, 1.88]), stillbirth (RR 1.14 [1.08, 1.22]), and very low birth weight (RR 1.10 [1.01, 1.21]). Relative to a 18-36 month IDI, women with long IDI had increased risk of maternal death (RR 1.54 [1.10, 2.16]), neonatal death (RR = 1.25 [1.14, 1.38]), stillbirth (RR = 1.50 [1.38, 1.62]), low birth weight (RR = 1.22 [1.17, 1.27]), and very low birth weight (RR = 1.47 [1.32,1.64]). Short and long IDIs were also associated with increased risk of obstructed labor, hemorrhage, hypertensive disorders, fetal malposition, infection, hospitalization, preterm delivery, and neonatal hospitalization. CONCLUSIONS: IDI varies by site. When compared to 18-36 month IDI, women with both short IDI and long IDI had increased risk of adverse maternal and neonatal outcomes. TRIAL REGISTRATION: The MNHR is registered at NCT01073475 .

Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.

OBJECTIVES: Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN: The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts. MAIN OUTCOME MEASURES: 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS: All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO4, and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072). CONCLUSIONS: As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.

Is the closest health facility the one used in pregnancy care-seeking? A cross-sectional comparative analysis of self-reported and modelled geographical access to maternal care in Mozambique, India and Pakistan.

BACKGROUND: Travel time to care is known to influence uptake of health services. Generally, pregnant women who take longer to transit to health facilities are the least likely to deliver in facilities. It is not clear if modelled access predicts fairly the vulnerability in women seeking maternal care across different spatial settings. OBJECTIVES: This cross-sectional analysis aimed to (i) compare travel times to care as modelled in a GIS environment with self-reported travel times by women seeking maternal care in Community Level Interventions for Pre-eclampsia: Mozambique, India and Pakistan; and (ii) investigate the assumption that women would seek care at the closest health facility. METHODS: Women were interviewed to obtain estimated travel times to health facilities (R). Travel time to the closest facility was also modelled (P) (closest facility tool (ArcGIS)) and time to facility where care was sought estimated (A) (route network layer finder (ArcGIS)). Bland-Altman analysis compared spatial variation in differences between modelled and self-reported travel times. Variations between travel times to the nearest facility (P) with modelled travel times to the actual facilities accessed (A) were analysed. Log-transformed data comparison graphs for medians, with box plots superimposed distributions were used. RESULTS: Modelled geographical access (P) is generally lower than self-reported access (R), but there is a geography to this relationship. In India and Pakistan, potential access (P) compared fairly with self-reported travel times (R) [P (H0: Mean difference = 0)] < .001, limits of agreement: [- 273.81; 56.40] and [- 264.10; 94.25] respectively. In Mozambique, mean differences between the two measures of access were significantly different from 0 [P (H0: Mean difference = 0) = 0.31, limits of agreement: [- 187.26; 199.96]]. CONCLUSION: Modelling access successfully predict potential vulnerability in populations. Differences between modelled (P) and self-reported travel times (R) are partially a result of women not seeking care at their closest facilities. Modelling access should not be viewed through a geographically static lens. Modelling assumptions are likely modified by spatio-temporal and/or socio-cultural settings. Geographical stratification of access reveals disproportionate variations in differences emphasizing the varied nature of assumptions across spatial settings. Trial registration ClinicalTrials.gov, NCT01911494. Registered 30 July 2013, https://clinicaltrials.gov/ct2/show/NCT01911494.

Early pregnancy loss in Belagavi, Karnataka, India 2014-2017: a prospective population-based observational study in a low-resource setting.

BACKGROUND: The prevalence of early pregnancy loss through miscarriage and medically terminated pregnancy (MTP) is largely unknown due to lack of early registration of pregnancies in most regions, and especially in low- and middle-income countries. Understanding the rates of early pregnancy loss as well as the characteristics of pregnant women who experience miscarriage or MTP can assist in better planning of reproductive health needs of women. METHODS: A prospective, population-based study was conducted in Belagavi District, south India. Using an active surveillance system of women of childbearing age, all women were enrolled as soon as possible during pregnancy. We evaluated rates and risk factors of miscarriage and MTP between 6 and 20 weeks gestation as well as rates of stillbirth and neonatal death. A hypothetical cohort of 1000 women pregnant at 6 weeks was created to demonstrate the impact of miscarriage and MTP on pregnancy outcome. RESULTS: A total of 30,166 women enrolled from 2014 to 2017 were included in this analysis. The rate of miscarriage per 1000 ongoing pregnancies between 6 and 8 weeks was 115.3, between 8 and 12 weeks the miscarriage rate was 101.9 per 1000 ongoing pregnancies and between 12 and 20 weeks the miscarriage rate was 60.3 per 1000 ongoing pregnancies. For those periods, the MTP rate was 40.2, 45.4, and 48.3 per 1000 ongoing pregnancies respectively. The stillbirth rate was 26/1000 and the neonatal mortality rate was 24/1000. The majority of miscarriages (96.6%) were unattended and occurred at home. The majority of MTPs occurred in a hospital and with a physician in attendance (69.6%), while 20.7% of MTPs occurred outside a health facility. Women who experienced a miscarriage were older and had a higher level of education but were less likely to be anemic than those with an ongoing pregnancy at 20 weeks. Women with MTP were older, had a higher level of education, higher parity, and higher BMI, compared to those with an ongoing pregnancy, but these results were not consistent across gestational age periods. CONCLUSIONS: Of women with an ongoing pregnancy at 6 weeks, about 60% will have a living infant at 28 days of age. Two thirds of the losses will be spontaneous miscarriages and one third will be secondary to a MTP. High maternal age and education were the risk factors associated with miscarriage and MTP. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475 .

The feasibility of task-sharing the identification, emergency treatment, and referral for women with pre-eclampsia by community health workers in India.

BACKGROUND: Hypertensive disorders are the second highest direct obstetric cause of maternal death after haemorrhage, accounting for 14% of maternal deaths globally. Pregnancy hypertension contributes to maternal deaths, particularly in low- and middle-income countries, due to a scarcity of doctors providing evidence-based emergency obstetric care. Task-sharing some obstetric responsibilities may help to reduce the mortality rates. This study was conducted to assess acceptability by the community and other healthcare providers, for task-sharing by community health workers (CHW) in the identification and initial care in hypertensive disorders in pregnancy. METHODS: This study was conducted in two districts of Karnataka state in south India. A total of 14 focus group discussions were convened with various community representatives: women of reproductive age (N = 6), male decision-makers (N = 2), female decision-makers (N = 3), and community leaders (N = 3). One-to-one interviews were held with medical officers (N = 2), private healthcare OBGYN specialists (N = 2), senior health administrators (N = 2), Taluka (county) health officers (N = 2), and obstetricians (N = 4). All data collection was facilitated by local researchers familiar with the setting and language. Data were subsequently transcribed, translated and analysed thematically using NVivo 10 software. RESULTS: There was strong community support for home visits by CHW to measure the blood pressure of pregnant women; however, respondents were concerned about their knowledge, training and effectiveness. The treatment with oral antihypertensive agents and magnesium sulphate in emergencies was accepted by community representatives but medical practitioners and health administrators had reservations, and insisted on emergency transport to a higher facility. The most important barriers for task-sharing were concerns regarding insufficient training, limited availability of medications, the questionable validity of blood pressure devices, and the ability of CHW to correctly diagnose and intervene in cases of hypertensive disorders of pregnancy. CONCLUSION: Task-sharing to community-based health workers has potential to facilitate early diagnosis of the hypertensive disorders of pregnancy and assist in the provision of emergency care. We identified some facilitators and barriers for successful task-sharing of emergency obstetric care aimed at reducing mortality and morbidity due to hypertensive disorders of pregnancy.

Availability and use of magnesium sulphate at health care facilities in two selected districts of North Karnataka, India.

BACKGROUND: Pre-eclampsia and eclampsia are major causes of maternal morbidity and mortality. Magnesium sulphate is accepted as the anticonvulsant of choice in these conditions and is present on the WHO essential medicines list and the Indian National List of Essential Medicines, 2015. Despite this, magnesium sulphate is not widely used in India for pre-eclampsia and eclampsia. In addition to other factors, lack of availability may be a reason for sub-optimal usage. This study was undertaken to assess the availability and use of magnesium sulphate at public and private health care facilities in two districts of North Karnataka, India. METHODS: A facility assessment survey was undertaken as part of the Community Level Interventions for Pre-eclampsia (CLIP) Feasibility Study which was undertaken prior to the CLIP Trials (NCT01911494). This study was undertaken in 12 areas of Belagavi and Bagalkote districts of North Karnataka, India and included a survey of 88 facilities. Data were collected in all facilities by interviewing the health care providers and analysed using Excel. RESULTS: Of the 88 facilities, 28 were public, and 60 were private. In the public facilities, magnesium sulphate was available in six out of 10 Primary Health Centres (60%), in all eight taluka (sub-district) hospitals (100%), five of eight community health centres (63%) and both district hospitals (100%). Fifty-five of 60 private facilities (92%) reported availability of magnesium sulphate. Stock outs were reported in six facilities in the preceding six months - five public and one private. Twenty-five percent weight/volume and 50% weight/volume concentration formulations were available variably across the public and private facilities. Sixty-eight facilities (77%) used the drug for severe pre-eclampsia and 12 facilities (13.6%) did not use the drug even for eclampsia. Varied dosing schedules were reported from facility to facility. CONCLUSIONS: Poor availability of magnesium sulphate was identified in many facilities, and stock outs in some. Individual differences in usage were identified. Ensuring a reliable supply of magnesium sulphate, standard formulations and recommendations of dosage schedules and training may help improve use; and decrease morbidity and mortality due to pre-eclampsia/ eclampsia. TRIAL REGISTRATION: The CLIP trial was registered with ClinicalTrials.gov ( NCT01911494 ).

A Comparison of Colorimetric Assessment of Vaginal pH with Nugent Score for the Detection of Bacterial Vaginosis.

Background. A Nugent score > 7 has been defined as the gold standard for the diagnosis for bacterial vaginosis (BV), though it is resource intensive and impractical as point of care testing. We sought to determine if colorimetric assessment of vaginal pH can accurately predict the occurrence of BV. Methods. We performed a planned subanalysis of 1,216 pregnant women between 13 0/7 and 19 6/7 weeks who underwent vaginal examination as part of a randomized controlled trial. Using a standardized technique, specimens were obtained for colorimetric assessment and two separate slides for Gram staining. These slides were subsequently evaluated by two independent blinded microbiologists for Nugent scoring. Results. Interrater reliability of the interpretation of the Nugent score was excellent (intraclass correlation-individual 0.93 (95 CI 0.92 to 0.94) and average 0.96 (95% CI 0.95 to 0.97)). The sensitivity of an elevated pH > 5 for a Nugent score > 7 was 21.9% while the specificity was 84.5%. The positive predictive value in our population was 33.7% with a negative predictive value of 75.0%. Conclusion. Though the Nugent score is internally accurate, the prediction of BV using vaginal pH alone has poor sensitivity and specificity.

Maternal and Newborn Health in Karnataka State, India: The Community Level Interventions for Pre-Eclampsia (CLIP) Trial's Baseline Study Results.

Existing vital health statistics registries in India have been unable to provide reliable estimates of maternal and newborn mortality and morbidity, and region-specific health estimates are essential to the planning and monitoring of health interventions. This study was designed to assess baseline rates as the precursor to a community-based cluster randomized control trial (cRCT)-Community Level Interventions for Pre-eclampsia (CLIP) Trial (NCT01911494; CTRI/2014/01/004352). The objective was to describe baseline demographics and health outcomes prior to initiation of the CLIP trial and to improve knowledge of population-level health, in particular of maternal and neonatal outcomes related to hypertensive disorders of pregnancy, in northern districts the state of Karnataka, India. The prospective population-based survey was conducted in eight clusters in Belgaum and Bagalkot districts in Karnataka State from 2013-2014. Data collection was undertaken by adapting the Maternal and Newborn Health registry platform, developed by the Global Network for Women's and Child Health Studies. Descriptive statistics were completed using SAS and R. During the period of 2013-2014, prospective data was collected on 5,469 pregnant women with an average age of 23.2 (+/-3.3) years. Delivery outcomes were collected from 5,448 completed pregnancies. A majority of the women reported institutional deliveries (96.0%), largely attended by skilled birth attendants. The maternal mortality ratio of 103 (per 100,000 livebirths) was observed during this study, neonatal mortality ratio was 25 per 1,000 livebirths, and perinatal mortality ratio was 50 per 1,000 livebirths. Despite a high number of institutional deliveries, rates of stillbirth were 2.86%. Early enrollment and close follow-up and monitoring procedures established by the Maternal and Newborn Health registry allowed for negligible lost to follow-up. This population-level study provides regional rates of maternal and newborn health in Belgaum and Bagalkot in Karnataka over 2013-14. The mortality ratios and morbidity information can be used in planning interventions and monitoring indicators of effectiveness to inform policy and practice. Comprehensive regional epidemiologic data, such as that provided here, is essential to gauge improvements and challenges in maternal health, as well as track disparities found in rural areas.

Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India.

BACKGROUND: In India, the hypertensive disorders of pregnancy and postpartum haemorrhage are responsible for nearly 40 % of all maternal deaths. Most of these deaths occur in primary health settings which frequently lack essential equipment and medication, are understaffed, and have limited or no access to specialist care. Community health care workers are regarded as essential providers of basic maternity care; and the quality of care they provide is dependent on the level of knowledge and skills they possess. However, there is limited research regarding their ability to manage pregnancy complications. This study aims to describe the current state of knowledge regarding pre-eclampsia and eclampsia among community health care workers (auxiliary nurse midwives, accredited social health activists, staff nurses) in northern Karnataka, India. Furthermore, this study describes the treatment approaches used by various cadres of community health workers for these conditions. The findings of this study can help plan focussed training sessions to build upon their strengths and to address the identified gaps. METHODS: Data were collected as part of a larger study aimed at assessing the feasibility of community-based treatment for pre-eclampsia. Eight focus group discussions were conducted in 2012-2013 in northern Karnataka State: four with staff nurses and auxiliary nurse midwives and four with accredited social health activists. In addition, twelve auxiliary nurse midwives and staff nurses completed questionnaires to explore their competence and self-efficacy in managing pre-eclampsia. Qualitative data were audio-recorded, transcribed verbatim and translated for thematic analysis using NVivo 10. RESULTS: Community health workers described their understanding of the origins of hypertension and seizures in pregnancy. Psychological explanations of hypertension were most commonly reported: stress, tension, and fear. The most common explanation for eclampsia was not receiving a tetanus vaccination. Despite some common misperceptions regarding aetiology, these community health workers demonstrated a good grasp of the potential consequences of hypertension in pregnancy. According to auxiliary nurse midwives and staff nurses, if hypertension was detected they encouraged rest, decreased salt intake, iron supplementation and tetanus vaccination. In addition, some staff nurses administered antihypertensives, MgSO4, or other anticonvulsants. All auxiliary nurse midwives had some awareness of MgSO4, but none had administered it themselves. CONCLUSIONS: This study showed that knowledge regarding the aetiology of pre-eclampsia was limited. Nevertheless, their basic knowledge and skills could be strengthened to more effectively manage the hypertensive disorders of pregnancy in their communities. TRIAL REGISTRATION: NCT01911494.

Community perceptions of pre-eclampsia in rural Karnataka State, India: a qualitative study.

BACKGROUND: Maternal deaths have been attributed in large part to delays in recognition of illness, timely transport to facility, and timely treatment once there. As community perceptions of pregnancy and their complications are critical to averting maternal morbidity and mortality, this study sought to contribute to the literature and explore community-based understandings of pre-eclampsia and eclampsia. METHODS: The study was conducted in rural Karnataka State, India, in 2012-2013. Fourteen focus groups were held with the following community stakeholders: three with community leaders (n = 27), two with male decision-makers (n = 19), three with female decision-makers (n = 41), and six with reproductive age women (n = 132). Focus groups were facilitated by local researchers with clinical and research expertise. Discussions were audio-recorded, transcribed verbatim and translated to English for thematic analysis using NVivo 10. RESULTS: Terminology exists in the local language (Kannada) to describe convulsions and hypertension, but there were no terms that are specific to pregnancy. Community participants perceived stress, tension and poor diet to be precipitants of hypertension in pregnancy. Seizures in pregnancy were thought to be brought on by anaemia, poor medical adherence, lack of tetanus toxoid immunization, and exposure in pregnancy to fire or water. Sweating, fatigue, dizziness-unsteadiness, swelling, and irritability were perceived to be signs of hypertension, which was recognized to have the potential to lead to eclampsia or death. Home remedies, such as providing the smell of onion, placing an iron object in the hands, or squeezing the fingers and toes, were all used regularly to treat seizures prior to accessing facility-based care although transport is not delayed. CONCLUSIONS: It is evident that 'pre-eclampsia' and 'eclampsia' are not well-known; instead hypertension and seizures are perceived as conditions that may occur during or outside pregnancy. Improving community knowledge about, and modifying attitudes towards, hypertension in pregnancy and its complications (including eclampsia) has the potential to address community-based delays in disease recognition and delays in treatment that contribute to maternal and perinatal morbidity and mortality. Advocacy and educational initiatives should be designed to target knowledge gaps and potentially harmful practices, and respond to cultural understandings of disease. TRIAL REGISTRATION: NCT01911494.

Utilization of maternal health care services and their determinants in Karnataka State, India.

BACKGROUND: Karnataka State continues to have the highest rates of maternal mortality in south India at 144/100,000 live births, but lower than the national estimates of 190-220/100,000 live births. Various barriers exist to timely and appropriate utilization of services during pregnancy, childbirth and postpartum. This study aimed to describe the patterns and determinants of routine and emergency maternal health care utilization in rural Karnataka State, India. METHODS: This study was conducted in Karnataka in 2012-2013. Purposive sampling was used to convene twenty three focus groups and twelve individual interviews with community and health system representatives: Auxiliary Nurse Midwives and Staff Nurses, Accredited Social Health Activists, community leaders, male decision-makers, female decision-makers, women of reproductive age, medical officers, private health care providers, senior health administrators, District health officers, and obstetricians. Local researchers familiar with the setting and language conducted all focus groups and interviews, these researchers were not known to community participants. All discussions were audio recorded, transcribed, and translated to English for analysis. A thematic analysis approach was taken utilizing an a priori thematic framework as well as inductive identification of themes. RESULTS: Most women in the focus groups reported regular antenatal care attendance, for an average of four visits, and more often for high-risk pregnancies. Antenatal care was typically delivered at the periphery by non-specialised providers. Participants reported that sought was care women experienced danger signs of complications. Postpartum care was reportedly rare, and mainly sought for the purpose of neonatal care. Factors that influenced women's care-seeking included their limited autonomy, poor access to and funding for transport for non-emergent conditions, perceived poor quality of health care facilities, and the costs of care. CONCLUSIONS: Rural south Indian communities reported regular use of health care services during pregnancy and for delivery. Uptake of maternity care services was attributed to new government programmes and increased availability of maternity services; nevertheless, some women delayed disclosure of pregnancy and first antenatal visit. Community-based initiatives should be enhanced to encourage early disclosure of pregnancies and to provide the community information regarding the importance of facility-based care. Health facility infrastructure in rural Karnataka should also be enhanced to ensure a consistent power supply and improved cleanliness on the wards. TRIAL REGISTRATION: NCT01911494.

Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings.

BACKGROUND: To describe quantitative data quality monitoring and performance metrics adopted by the Global Network's (GN) Maternal Newborn Health Registry (MNHR), a maternal and perinatal population-based registry (MPPBR) based in low and middle income countries (LMICs). METHODS: Ongoing prospective, population-based data on all pregnancy outcomes within defined geographical locations participating in the GN have been collected since 2008. Data quality metrics were defined and are implemented at the cluster, site and the central level to ensure data quality. Quantitative performance metrics are described for data collected between 2010 and 2013. RESULTS: Delivery outcome rates over 95% illustrate that all sites are successful in following patients from pregnancy through delivery. Examples of specific performance metric reports illustrate how both the metrics and reporting process are used to identify cluster-level and site-level quality issues and illustrate how those metrics track over time. Other summary reports (e.g. the increasing proportion of measured birth weight compared to estimated and missing birth weight) illustrate how a site has improved quality over time. CONCLUSION: High quality MPPBRs such as the MNHR provide key information on pregnancy outcomes to local and international health officials where civil registration systems are lacking. The MNHR has measures in place to monitor data collection procedures and improve the quality of data collected. Sites have increasingly achieved acceptable values of performance metrics over time, indicating improvements in data quality, but the quality control program must continue to evolve to optimize the use of the MNHR to assess the impact of community interventions in research protocols in pregnancy and perinatal health. TRIAL REGISTRATION NUMBER: NCT01073475.

Lost to follow-up among pregnant women in a multi-site community based maternal and newborn health registry: a prospective study.

BACKGROUND: It is important when conducting epidemiologic studies to closely monitor lost to follow up (LTFU) rates. A high LTFU rate may lead to incomplete study results which in turn can introduce bias to the trial or study, threatening the validity of the findings. There is scarce information on LTFU in prospective community-based perinatal epidemiological studies. This paper reports the rates of LTFU, describes socio-demographic characteristics, and pregnancy/delivery outcomes of mothers LTFU in a large community-based pregnancy registry study. METHODS: Data were from a prospective, population-based observational study of the Global Network for Women's and Children's Health Research Maternal Newborn Health Registry (MNHR). This is a multi-centre, international study in which pregnant women were enrolled in mid-pregnancy, followed through parturition and 42 days post-delivery. Risk for LTFU was calculated within a 95%CI. RESULTS: A total of 282,626 subjects were enrolled in this study, of which 4,893 were lost to follow-up. Overall, there was a 1.7% LTFU to follow up rate. Factors associated with a higher LTFU included mothers who did not know their last menstrual period (RR 2.2, 95% CI 1.1, 4.4), maternal age of < 20 years (RR 1.2, 95% CI 1.1, 1.3), women with no formal education (RR 1.2, 95% CI 1.1, 1.4), and attending a government clinic for antenatal care (RR 2.0, 95% CI 1.4, 2.8). Post-natal factors associated with a higher LTFU rate included a newborn with feeding problems (RR 1.6, 94% CI 1.2, 2.2). CONCLUSIONS: The LTFU rate in this community-based registry was low (1.7%). Maternal age, maternal level of education, pregnancy status at enrollment and using a government facility for ANC are factors associated with being LTFU. Strategies to ensure representation and high retention in community studies are important to informing progress toward public health goals. TRIAL REGISTRATION: Registration at the Clinicaltrials.gov (ID# NCT01073475).