The ability and safety of community-based health workers to safely initiate lifesaving therapies for pre-eclampsia in Ogun State, Nigeria: An analysis of 260 community treatments with MgSO4 and/or methyldopa.

OBJECTIVES: To evaluate community-based health workers' ability to identify cases of hypertension in pregnancy, safely deliver methyldopa and magnesium sulphate and make referrals when appropriate. STUDY DESIGN: This was part of Nigeria Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494). Community-based Health Workers (CHW) recruited pregnant women from five Local Government Areas (clusters) and used mobile health aid for clinical assessment of pre-eclampsia. MAIN OUTCOME MEASURES: The primary outcome was the number of adverse events that occurred after the administration of magnesium sulphate and/or methyldopa to pregnant women by CHWs. FINDINGS: Of 8790 women receiving mobile health-guided care, community-based health workers in Nigeria provided 309 women with hypertension (4.2% of delivered women), and safely administered 142 doses of intramuscular magnesium sulphate. Community Heath Extension Workers (CHEWs) and nurses gave fifty-two and sixty-seven doses of intramuscular magnesium sulphate respectively, twenty-three doses were given by other health care workers (midwives, community health officers, health assistants). The high rate of administration by nurses can be explained by turf protection as well as their seniority within the health system. Also, CHEWs and nurses gave 124 doses of oral methyldopa and 126 urgent referrals were completed. There were no complications related to administration of treatment or referral. INTERPRETATION: These findings demonstrate the ability of community-based health workers to safely administer methyldopa and intramuscular magnesium sulphate. The use of task-sharing, therefore, could drastically reduce the three delays (triage, transport and treatment) associated with high maternal mortality and morbidity in rural communities in low- and middle-income countries.

Population-level data on antenatal screening for proteinuria; India, Mozambique, Nigeria, Pakistan.

OBJECTIVE: To estimate the prevalence and prognosis of proteinuria at enrolment in the 27 intervention clusters of the Community-Level Interventions for Pre-eclampsia cluster randomized trials. METHODS: We identified pregnant women eligible for inclusion in the trials in their communities in four countries (2013-2017). We included women who delivered by trial end and received an intervention antenatal care visit. The intervention was a community health worker providing supplementary hypertension-oriented care, including proteinuria assessment by visual assessment of urinary dipstick at the first visit and all subsequent visits when hypertension was detected. In a multilevel regression model, we compared baseline prevalence of proteinuria (≥ 1+ or ≥ 2+) across countries. We compared the incidence of subsequent complications by baseline proteinuria. FINDINGS: Baseline proteinuria was detected in less than 5% of eligible pregnancies in each country (India: 234/6120; Mozambique: 94/4234; Nigeria: 286/7004; Pakistan: 315/10 885), almost always with normotension (India: 225/234; Mozambique: 93/94; Nigeria: 241/286; Pakistan: 264/315). There was no consistent relationship between baseline proteinuria (either ≥ 1+ or ≥ 2+) and progression to hypertension, maternal mortality or morbidity, birth at < 37 weeks, caesarean section delivery or perinatal mortality or morbidity. If proteinuria testing were restricted to women with hypertension, we projected annual cost savings of 153 223 981 United States dollars (US$) in India, US$ 9 055 286 in Mozambique, US$ 53 181 933 in Nigeria and US$ 38 828 746 in Pakistan. CONCLUSION: Our findings question the recommendations to routinely evaluate proteinuria at first assessment in pregnancy. Restricting proteinuria testing to pregnant women with hypertension has the potential to save resources.

The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis.

BACKGROUND: Most pregnancy hypertension estimates in less-developed countries are from cross-sectional hospital surveys and are considered overestimates. We estimated population-based rates by standardised methods in 27 intervention clusters of the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials. METHODS AND FINDINGS: CLIP-eligible pregnant women identified in their homes or local primary health centres (2013-2017). Included here are women who had delivered by trial end and received a visit from a community health worker trained to provide supplementary hypertension-oriented care, including standardised blood pressure (BP) measurement. Hypertension (BP ≥ 140/90 mm Hg) was defined as chronic (first detected at <20 weeks gestation) or gestational (≥20 weeks); pre-eclampsia was gestational hypertension plus proteinuria or a pre-eclampsia-defining complication. A multi-level regression model compared hypertension rates and types between countries (p < 0.05 considered significant). In 28,420 pregnancies studied, women were usually young (median age 23-28 years), parous (53.7%-77.3%), with singletons (≥97.5%), and enrolled at a median gestational age of 10.4 (India) to 25.9 weeks (Mozambique). Basic education varied (22.8% in Pakistan to 57.9% in India). Pregnancy hypertension incidence was lower in Pakistan (9.3%) than India (10.3%), Mozambique (10.9%), or Nigeria (10.2%) (p = 0.001). Most hypertension was diastolic only (46.4% in India, 72.7% in Pakistan, 61.3% in Mozambique, and 63.3% in Nigeria). At first presentation with elevated BP, gestational hypertension was most common diagnosis (particularly in Mozambique [8.4%] versus India [6.9%], Pakistan [6.5%], and Nigeria [7.1%]; p < 0.001), followed by pre-eclampsia (India [3.8%], Nigeria [3.0%], Pakistan [2.4%], and Mozambique [2.3%]; p < 0.001) and chronic hypertension (especially in Mozambique [2.5%] and Nigeria [2.8%], compared with India [1.2%] and Pakistan [1.5%]; p < 0.001). Inclusion of additional diagnoses of hypertension and related complications, from household surveys or facility record review (unavailable in Nigeria), revealed higher hypertension incidence: 14.0% in India, 11.6% in Pakistan, and 16.8% in Mozambique; eclampsia was rare (<0.5%). CONCLUSIONS: Pregnancy hypertension is common in less-developed settings. Most women in this study presented with gestational hypertension amenable to surveillance and timed delivery to improve outcomes. TRIAL REGISTRATION: This study is a secondary analysis of a clinical trial - ClinicalTrials.gov registration number NCT01911494.

The CRADLE vital signs alert: qualitative evaluation of a novel device designed for use in pregnancy by healthcare workers in low-resource settings.

BACKGROUND: Vital signs measurement can identify pregnant and postpartum women who require urgent treatment or referral. In low-resource settings, healthcare workers have limited access to accurate vital signs measuring devices suitable for their environment and training. The CRADLE Vital Signs Alert (VSA) is a novel device measuring blood pressure and pulse that is accurate in pregnancy and designed for low-resource settings. Its traffic light early warning system alerts healthcare workers to the need for escalation of care for women with hypertension, haemorrhage or sepsis. This study evaluated the usability and acceptability of the CRADLE VSA device. METHODS: Evaluation was conducted in community and primary care settings in India, Mozambique and Nigeria and tertiary hospitals in South Africa. Purposeful sampling was used to convene 155 interviews and six focus groups with healthcare workers using the device (n = 205) and pregnant women and their family members (n = 41). Interviews and focus groups were conducted in the local language and audio-recorded, transcribed and translated into English for analysis. Thematic analysis was undertaken using an a priori thematic framework, as well as an inductive approach. RESULTS: Most healthcare workers perceived the CRADLE device to be easy to use and accurate. The traffic lights early warning system was unanimously reported positively, giving healthcare workers confidence with decision-making and a sense of professionalism. However, a minority in South Africa described manual inflation as tiring, particularly when measuring vital signs in obese and hypertensive women (n = 4) and a few South African healthcare workers distrusted the device's accuracy (n = 7). Unanimously, pregnant women liked the CRADLE device. The traffic light early warning system gave women and their families a better understanding of the importance of vital signs in pregnancy and during the postpartum period. CONCLUSION: The CRADLE device was well accepted by healthcare workers from a range of countries and levels of facility, including those with no previous vital signs measurement experience. The device motivated women to attend primary care and encouraged them to accept treatment and referral.

A process evaluation plan for assessing a complex community-based maternal health intervention in Ogun State, Nigeria.

BACKGROUND: Despite increased investment in community-level maternal health interventions, process evaluations of such interventions are uncommon, and can be instrumental in understanding mediating factors leading to outcomes. In Nigeria, where an unacceptably number of maternal deaths occur (maternal mortality ratio of 814/100,000 livebirths), the Community Level Interventions for Pre-eclampsia (CLIP) study (NCT01911494) aimed to reduce maternal and neonatal mortality and morbidity with a complex intervention of five interrelated components. Building from previous frameworks, we illustrate a methodology to evaluate implementation processes of the complex CLIP intervention, assess mechanisms of impact and identify emerging unintended causal pathways. METHODS: The study was conducted from 2013-2016 in five Local Government Areas in Ogun State, Nigeria. A six-step approach was developed to evaluate key constructs of context (external factors related to intervention), implementation (fidelity, dose, reach, and adaption) and mechanisms of impact (unintended outcomes and mediating pathways). The steps are: 1) describing the intervention by a logic model, 2) defining acceptable delivery, 3) formulating questions, 4) determining methodology, 5) planning resources in context, lastly, step 6) finalising the plan in consideration with relevant stakeholders. RESULTS: Quantitative data were collected from 32,785 antenatal and postnatal visits at the primary health care level, from 66 community engagement sessions, training assessments of community health workers, and standard health facility questionnaires. Forty-three focus group discussions, 38 in-depth interviews, and 23 structured observations were conducted to capture qualitative data. A total of 103 community engagement reports and 182 suspected pre-eclampsia case reports were purposively collected. Timing of data collection was staggered to understand feedback mechanisms that may have resulted from the delivery of the intervention. Data will be analysed using R and NVivo. Diffusions of innovations and realist evaluation theories will underpin analysis of the interaction between context, mechanisms and outcomes. CONCLUSION: This comprehensive approach can serve as a guide for researchers and policy makers to plan the evaluation of similar complex health interventions in resource-constrained settings, and to aid in measuring 'effectiveness' of interventions and not just 'efficacy'. TRIAL REGISTRATION: This research is a part of the Community Level Interventions for Pre-eclampsia Study, NCT01911494. The trial is registered in Clinicaltrials.gov, the URL is https://clinicaltrials.gov/ct2/show/NCT01911494 The trial was registered on June 28, 2013 and the first participant was enrolled for intervention on March 1, 2014.

Human resource constraints and the prospect of task-sharing among community health workers for the detection of early signs of pre-eclampsia in Ogun State, Nigeria.

BACKGROUND: The dearth of health personnel in low income countries has attracted global attention. Ways as to how health care services can be delivered in a more efficient and effective way using available health personnel are being explored. Task-sharing expands the responsibilities of low-cadre health workers and allows them to share these responsibilities with highly qualified health care providers in an effort to best utilize available human resources. This is appropriate in a country like Nigeria where there is a shortage of qualified health professionals and a huge burden of maternal mortality resulting from obstetric complications like pre-eclampsia. This study examines the prospect for task-sharing among Community Health Extension Workers (CHEW) for the detection of early signs of pre-eclampsia, in Ogun State, Nigeria. METHODS: This study is part of a larger community-based trial evaluating the acceptability of community treatment for severe pre-eclampsia in Ogun State, Nigeria. Data was collected between 2011 and 2012 using focus group discussions; seven with CHEWs (n = 71), three with male decision-makers (n = 35), six with community leaders (n = 68), and one with member of the Society of Obstetricians and Gynaecologists of Nigeria (n = 9). In addition, interviews were conducted with the heads of the local government administration (n = 4), directors of planning (n = 4), medical officers (n = 4), and Chief Nursing Officers (n = 4). Qualitative data were analysed using NVivo version 10.0 3 computer software. RESULTS: The non-availability of health personnel is a major challenge, and has resulted in a high proportion of facility-based care performed by CHEWs. As a result, CHEWs often take on roles that are designated for senior health workers. This role expansion has exposed CHEWs to the basics of obstetric care, and has resulted in informal task-sharing among the health workers. The knowledge and ability of CHEWs to perform basic clinical assessments, such as measure blood pressure is not in doubt. Nevertheless, there were divergent views by senior and junior cadres of health practitioners about CHEWs' abilities in providing obstetric care. Similarly, there were concerns by various stakeholders, particularly the CHEWs themselves, on the regulatory restrictions placed on them by the Standing Order. CONCLUSION: Generally, the extent to which obstetric tasks could be shifted to community health workers will be determined by the training provided and the extent to which the observed barriers are addressed. TRIAL REGISTRATION: NCT01911494.

Community perceptions of pre-eclampsia and eclampsia in Ogun State, Nigeria: a qualitative study.

BACKGROUND: Pre-eclampsia is a complication of pregnancy responsible for high rates of morbidity and mortality, particularly in sub-Saharan Africa. When undetected or poorly managed, it may progress to eclampsia which further worsens the prognosis. While most studies examining pre-eclampsia have used a bio-medical model, this study recognizes the role of the socio-cultural environment, in order to understand perceptions of pre-eclampsia within the community. METHODS: The study was conducted in Ogun State, Nigeria in 2011-2012. Data were obtained through twenty-eight focus group discussions; seven with pregnant women (N = 80), eight with new mothers (N = 95), three with male decision-makers (N = 35), six with community leaders (N = 68), and three with traditional birth attendants (N = 36). Interviews were also conducted with the heads of the local traditional birth attendants (N = 4) and with community leaders (N = 5). Data were transcribed verbatim and analysed in NVivo 10 software. RESULTS: There was no terminology reportedly used for pre-eclampsia in the native language - Yoruba; however, hypertension has several terms independent of pregnancy status. Generally, 'gìrì âlábôyún' describes seizures specific to pregnancy. The cause of hypertension in pregnancy was thought to be due to depressive thoughts as a result of marital conflict and financial worries, while seizures in pregnancy were perceived to result from prolonged exposure to cold. There seemed to be no traditional treatment for hypertension. However for seizures the use of herbs, concoctions, incisions, and topical application of black soap were widespread. CONCLUSION: This study illustrates that knowledge of pre-eclampsia and eclampsia are limited amongst communities of Ogun State, Nigeria. Findings reveal that pre-eclampsia was perceived as a stress-induced condition, while eclampsia was perceived as a product of prolonged exposure to cold. Thus, heat-related local medicines and herbal concoctions were the treatment options. Perceptions anchored on cultural values and lack of adequate and focused public health awareness is a major constraint to knowledge of the aetiology and treatment of the conditions. A holistic approach is recommended for sensitization at the community level and the need to change the community perceptions of pre-eclampsia remains a challenge. TRIAL REGISTRATION: NCT01911494 .

Determinants of health care seeking behaviour during pregnancy in Ogun State, Nigeria.

BACKGROUND: In Nigeria, women too often suffer the consequences of serious obstetric complications that may lead to death. Delay in seeking care (phase I delay) is a recognized contributor to adverse pregnancy outcomes. This qualitative study aimed to describe the health care seeking practices in pregnancy, as well as the socio-cultural factors that influence these actions. METHODS: The study was conducted in Ogun State, in south-western Nigeria. Data were collected through focus group discussions with pregnant women, recently pregnant mothers, male decision-makers, opinion leaders, traditional birth attendants, health workers, and health administrators. A thematic analysis approach was used with QSR NVivo version 10. RESULTS: Findings show that women utilized multiple care givers during pregnancy, with a preference for traditional providers. There was a strong sense of trust in traditional medicine, particularly that provided by traditional birth attendants who are long-term residents in the community. The patriarchal c influenced health-seeking behaviour in pregnancy. Economic factors contributed to the delay in access to appropriate services. There was a consistent concern regarding the cost barrier in accessing health services. The challenges of accessing services were well recognised and these were greater when referral was to a higher level of care which in most cases attracted unaffordable costs. CONCLUSION: While the high cost of care is a deterrent to health seeking behaviour, the cost of death of a woman or a child to the family and community is immeasurable. The use of innovative mechanisms for health care financing may be beneficial for women in these communities to reduce the barrier of high cost services. To reduce maternal deaths all stakeholders must be engaged in the process including policy makers, opinion leaders, health care consumers and providers. Underlying socio-cultural factors, such as structure of patriarchy, must also be addressed to sustainably improve maternal health. TRIAL REGISTRATION: NCT01911494.

The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design.

BACKGROUND: Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude. METHODS: A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance. RESULTS: Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement. CONCLUSIONS: Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts. TRIAL REGISTRATION: NCT01911494.

National data system on near miss and maternal death: shifting from maternal risk to public health impact in Nigeria.

BACKGROUND: The lack of reliable and up-to-date statistics on maternal deaths and disabilities remains a major challenge to the implementation of Nigeria's Road Map to Accelerate the Millennium Development Goal related to Maternal Health (MDG-5). There are currently no functioning national data sources on maternal deaths and disabilities that could serve as reference points for programme managers, health advocates and policy makers. While awaiting the success of efforts targeted at overcoming the barriers facing establishment of population-based data systems, referral institutions in Nigeria can contribute their quota in the quest towards MDG-5 by providing good quality and reliable information on maternal deaths and disabilities on a continuous basis. This project represents the first opportunity to initiate a scientifically sound and reliable quantitative system of data gathering on maternal health profile in Nigeria. OBJECTIVE: The primary objective is to create a national data system on maternal near miss (MNM) and maternal mortality in Nigerian public tertiary institutions. This system will conduct periodically, both regionally and at country level, a review of the magnitude of MNM and maternal deaths, nature of events responsible for MNM and maternal deaths, indices for the quality of care for direct obstetric complications and the health service events surrounding these complications, in an attempt to collectively define and monitor the standard of comprehensive emergency obstetric care in the country. METHODS: This will be a nationwide cohort study of all women who experience MNM and those who die from pregnancy, childbirth and puerperal complications using uniform criteria among women admitted in tertiary healthcare facilities in the six geopolitical zones in Nigeria. This will be accomplished by establishing a network of all public tertiary obstetric referral institutions that will prospectively collect specific information on potentially fatal maternal complications. For every woman enrolled, the health service events (care pathways) within the facility will be evaluated to identify areas of substandard care/avoidable factors through clinical audit by the local research team. A summary estimate of the frequencies of MNM and maternal deaths will be determined at intervals and indicators of quality of care (case fatality rate, both total and cause-specific and mortality index) will be evaluated at facility, regional and country levels. MANAGEMENT: Overall project management will be from the Centre for Research in Reproductive Health (CRRH), Sagamu, Nigeria. There will be at least two meetings and site visits for efficient coordination of the project by regional coordinators and central coordinating staff. Data will be transferred electronically by hospital and regional coordinators and managed at the Data Management Unit of CRRH, Sagamu, Nigeria. EXPECTED OUTCOMES: The outcome of the study would provide useful information to the health practitioners, policy-makers and international partners on the strengths and weaknesses of the infrastructures provided for comprehensive emergency obstetric care in Nigeria. The successful implementation of this project will pave way for the long-awaited Confidential Enquiries into Maternal Deaths that would guide the formulation and or revision of obstetric policies and practices in Nigeria. Lessons learnt from the establishment of this data system can also be used to set up similar structures at lower levels of healthcare delivery in Nigeria.