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

Larvicidal Efficacy of a Tropical Seaweed (Dictyota ciliolata) Extracts on Vectorial Mosquito Species and Non-Target Effect on Guppy Fish (Poecilia reticulata)

Extracts of seaweeds are promising candidates for eco-friendly, safe, and biodegradable larvicides and as alternatives to chemical larvicides used in mosquito control strategies. This study evaluated the larvicidal effects of Dictyota ciliolata on the mosquito larvae of Aedes aegypti, Anopheles gambiae, and Culex quinquefasciatus. The seaweed was extracted using ethanol and methanol. The larvicidal assays were conducted per WHO standards by exposing twenty 4th instar larvae to 100, 200, 300, 400, 500, and 600 mg/L of the derived extracts. The LC50 and LC95 values were obtained by calculating the probit values of the observed mortalities. LC50 of the ethanolic and methanolic extracts of Dictyota ciliolata against Anopheles gambiae larvae were 238.45 mg/L and 497.28 mg/L respectively; 179.02 mg/L and 224.96 mg/L respectively against Aedes aegypti, and 167.49 mg/L and 226.69 mg/L respectively for Culex quinquefasciatus. The results established that ethanolic and methanolic seaweed extracts were most influential on Culex quinquefasciatus followed by Aedes aegypti and Anopheles gambiae. Although mortalities were recorded for Poecilia reticulata, such may not be enough to de-emphasize the observed larvicidal potentials of Dictyota ciliolata as some other factors could have been responsible for the said mortalities in the non-target species

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 \u3c20 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 \u3c 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 \u3c 0.001), followed by pre-eclampsia (India [3.8%], Nigeria [3.0%], Pakistan [2.4%], and Mozambique [2.3%]; p \u3c 0.001) and chronic hypertension (especially in Mozambique [2.5%] and Nigeria [2.8%], compared with India [1.2%] and Pakistan [1.5%]; p \u3c 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 (\u3c0.5%). 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 outcome

Additional file 1: of Community perceptions of pre-eclampsia and eclampsia in Ogun State, Nigeria: a qualitative study

Peer review reports. (PDF 274 kb

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.Medicine, Faculty ofOther UBCNon UBCObstetrics and Gynaecology, Department ofReviewedFacult

Additional file 1: of Determinants of health care seeking behaviour during pregnancy in Ogun State, Nigeria

Peer review reports. (PDF 329 kb