Community Level Interventions For Pre-eclampsia Research Articles

Transitioning from the “Three Delays” to a focus on continuity of care: a qualitative analysis of maternal deaths in rural Pakistan and Mozambique

BackgroundThe Three Delays Framework was instrumental in the reduction of maternal mortality leading up to, and during the Millennium Development Goals. However, this paper suggests the original framework might be reconsidered, now that most mothers give birth in facilities, the quality and continuity of the clinical care is of growing importance.MethodsThe paper explores the factors that contributed to maternal deaths in rural Pakistan and Mozambique, using 76 verbal autopsy narratives from the Community Level Interventions for Pre-eclampsia (CLIP) Trial.ResultsQualitative analysis of these maternal death narratives in both countries reveals an interplay of various influences, such as, underlying risks and comorbidities, temporary improvements after seeking care, gaps in quality care in emergencies, convoluted referral systems, and arrival at the final facility in critical condition. Evaluation of these narratives helps to reframe the pathways of maternal mortality beyond a single journey of care-seeking, to update the categories of seeking, reaching and receiving care.ConclusionsThere is a need to supplement the pioneering “Three Delays Framework” to include focusing on continuity of care and the “Four Critical Connection Points”: (1) between the stages of pregnancy, (2) between families and health care workers, (3) between health care facilities and (4) between multiple care-seeking journeys.Trial registrationNCT01911494, Date Registered 30/07/2013.

The development and implementation of a community engagement strategy to improve maternal health in southern Mozambique.

Delays to seek medical help can contribute to maternal deaths particularly in community settings at home or on the road to a health facility. Community engagement (CE) can improve care-seeking behaviours and complements community-based interventions strengthening maternal health. The purpose of this paper is to describe the process undertaken to develop and implement a large-scale community engagement strategy in rural southern Mozambique. The CE strategy was developed within the context of the "Community-Level Interventions for Pre-eclampsia" (NCT01911494) conducted between 2015-2017 in southern Mozambique. Key CE messages included pregnancy complications and their warning signs, including pre-eclampsia and eclampsia, as well as emergency readiness, birth preparedness, decision-making mechanisms, transport options and information about the trial. CE meeting logs were used to record quantitative and qualitative information on demographic data and feedback. Quantitative data was analyzed using RStudio (RStudio Inc, Boston, United States) and community feedback was qualitatively analyzed on NVivo12 (QSR International, Melbourne, Australia). CE activities reached 19,169 participants during 4,239 meetings. CE activities were reported to be well received by community members though there was a relatively lower participation of men (3565 /18.6%). The use of recognized local leaders and personnel, such as community leaders, nurses and community health workers, allowed for greater acceptance of CE activities and maximized coverage of health messages in the community setting. Our CE strategy was effective in integrating maternal health promoting activities in routine care of community health workers and nurses in the area. Understanding district differences, engaging husbands, partners, mothers-in-law and community-level decision-makers to build local support for maternal health and flexibility to tailor messages to local needs were important in developing sustainable forms of CE. Better strategies are needed to effectively engage men in maternal health promotion who were less available due to working outside of the home or neighbourhoods.

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

ObjectiveTo 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.DesignThis study...

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

BackgroundIron-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.MethodsThe 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.ResultsOf 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.ConclusionIn 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.

Blood Pressure Thresholds in Pregnancy for Identifying Maternal and Infant Risk: A Secondary Analysis of Community-Level Interventions for Pre-Eclampsia (CLIP) Trial Data

(Abstracted from Lancet Glob Health 2021;9:e1119–e1128) Hypertension in pregnancy (HIP) has served as a marker for increased risk of adverse pregnancy outcomes, including fetal growth restriction, stillbirth, severe maternal morbidity, and maternal mortality. Traditionally, HIP has been defined as systolic blood pressure (sBP) of ≥140 mm Hg, diastolic BP (dBP) of ≥90 mm Hg, or both.

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.

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. 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. 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. 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. 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.

Causes and circumstances of maternal death: a secondary analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials cohort

SummaryBackgroundIncomplete vital registration systems mean that causes of death during pregnancy and childbirth are poorly understood in low-income and middle-income countries. To inform global efforts to reduce maternal mortality, we compared physician review and computerised analysis of verbal autopsies (interpreting verbal autopsies [InterVA] software), to understand their agreement on maternal cause of death and circumstances of mortality categories (COMCATs) in the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials.MethodsThe CLIP trials took place in India, Pakistan, and Mozambique, enrolling pregnant women aged 12–49 years between Nov 1, 2014, and Feb 28, 2017. 69 330 pregnant women were enrolled in 44 clusters (36 008 in the 22 intervention clusters and 33 322 in the 22 control clusters). In this secondary analysis of maternal deaths in CLIP, we included women who died in any of the 22 intervention clusters or 22 control clusters. Trained staff administered the WHO 2012 verbal autopsy after maternal deaths. Two physicians (and a third for consensus, if needed) reviewed trial surveillance data and verbal autopsies, and, in intervention clusters, community health worker-led visit data. They determined cause of death according to the WHO International Classification of Diseases-Maternal Mortality (ICD-MM). Verbal autopsies were also analysed by InterVA computer models (versions 4 and 5) to generate cause of death. COMCAT analysis was provided by InterVA-5 and, in India, by physician review of Maternal Newborn Health Registry data. Causes of death and COMCATs assigned by physician review, Inter-VA-4, and InterVA-5 were compared, with agreement assessed with Cohen's κ coefficient.FindingsOf 61 988 pregnancies with successful follow-up in the CLIP trials, 143 maternal deaths were reported (16 deaths in India, 105 in Pakistan, and 22 in Mozambique). The maternal death rate was 231 (95% CI 193–268) per 100 000 identified pregnancies. Most deaths were attributed to direct maternal causes (rather than indirect or undetermined causes as per ICD-MM classification), with fair to good agreement between physician review and InterVA-4 (κ=0·56 [95% CI 0·43–0·66]) or InterVA-5 (κ=0·44 [0·30–0·57]), and InterVA-4 and InterVA-5 (κ=0·72 [0·60–0·84]). The top three causes of death were the same by physician review, InterVA-4, and InterVA-5 (ICD-MM categories obstetric haemorrhage, non-obstetric complications, and hypertensive disorders); however, attribution of individual patient deaths to obstetric haemorrhage varied more between methods (physician review, 38 [27%] deaths; InterVA-4, 69 [48%] deaths; and InterVA-5, 82 [57%] deaths), than did attribution to non-obstetric causes (physician review, 39 [27%] deaths; InterVA-4, 37 [26%] deaths; and InterVA-5, 28 [20%] deaths) or hypertensive disorders (physician review, 23 [16%] deaths; InterVA-4, 25 [17%] deaths; and InterVA-5, 24 [17%] deaths). Agreement for all nine ICD-MM categories was fair for physician review versus InterVA-4 (κ=0·48 [0·38–0·58]), poor for physician review versus InterVA-5 (κ=0·36 [0·27–0·46]), and good for InterVA-4 versus InterVA-5 (κ=0·69 [0·59–0·79]). The most commonly assigned COMCATs by InterVA-5 were emergencies (68 [48%] of 143 deaths) and health systems (62 [43%] deaths), and by physician review (India only) were health systems (seven [44%] of 16 deaths) and inevitability (five [31%] deaths); agreement between InterVA-5 and physician review (India data only) was poor (κ=0·04 [0·00–0·15]).InterpretationOur findings indicate that InterVA-5 is less accurate than InterVA-4 at ascertaining causes and circumstances of maternal death, when compared with physician review. Our results suggest a need to improve the next iteration of InterVA, and for researchers and clinicians to preferentially use InterVA-4 when recording maternal deaths.FundingUniversity of British Columbia (grantee of the Bill & Melinda Gates Foundation).

Feasibility of task-sharing with community health workers for the identification, emergency management and referral of women with pre-eclampsia, in Mozambique

BackgroundMaternal mortality is an important public health problem in low-income countries. Delays in reaching health facilities and insufficient health care professionals call for innovative community-level solutions. There is limited evidence on the role of community health workers in the management of pregnancy complications. This study aimed to describe the feasibility of task-sharing the initial screening and initiation of obstetric emergency care for pre-eclampsia/eclampsia from the primary healthcare providers to community health workers in Mozambique and document healthcare facility preparedness to respond to referrals.MethodThe study took place in Maputo and Gaza Provinces in southern Mozambique and aimed to inform the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial. This was a mixed-methods study. The quantitative data was collected through self-administered questionnaires completed by community health workers and a health facility survey; this data was analysed using Stata v13. The qualitative data was collected through focus group discussions and in-depth interviews with various community groups, health care providers, and policymakers. All discussions were audio-recorded and transcribed verbatim prior to thematic analysis using QSR NVivo 10. Data collection was complemented by reviewing existing documents regarding maternal health and community health worker policies, guidelines, reports and manuals.ResultsCommunity health workers in Mozambique were trained to identify the basic danger signs of pregnancy; however, they have not been trained to manage obstetric emergencies. Furthermore, barriers at health facilities were identified, including lack of equipment, shortage of supervisors, and irregular drug availability. All primary and the majority of secondary-level facilities (57%) do not provide blood transfusions or have surgical capacity, and thus such cases must be referred to the tertiary-level. Although most healthcare facilities (96%) had access to an ambulance for referrals, no transport was available from the community to the healthcare facility.ConclusionsThis study showed that task-sharing for screening and pre-referral management of pre-eclampsia and eclampsia were deemed feasible and acceptable at the community-level, but an effort should be in place to address challenges at the health system level.

Blood pressure thresholds in pregnancy for identifying maternal and infant risk: a secondary analysis of Community-Level Interventions for Pre-eclampsia (CLIP) trial data

SummaryBackgroundBlood pressure measurement is a marker of antenatal care quality. In well resourced settings, lower blood pressure cutoffs for hypertension are associated with adverse pregnancy outcomes. We aimed to study the associations between blood pressure thresholds and adverse outcomes and the diagnostic test properties of these blood pressure cutoffs in low-resource settings.MethodsWe did a secondary analysis of data from 22 intervention clusters in the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials (NCT01911494) in India (n=6), Mozambique (n=6), and Pakistan (n=10). We included pregnant women aged 15–49 years (12–49 years in Mozambique), identified in their community by trained community health workers, who had data on blood pressure measurements and outcomes. The trial was unmasked. Maximum blood pressure was categorised as: normal blood pressure (systolic blood pressure [sBP] <120 mm Hg and diastolic blood pressure [dBP] <80 mm Hg), elevated blood pressure (sBP 120–129 mm Hg and dBP <80 mm Hg), stage 1 hypertension (sBP 130–139 mm Hg or dBP 80–89 mm Hg, or both), non-severe stage 2 hypertension (sBP 140–159 mm Hg or dBP 90–109 mm Hg, or both), or severe stage 2 hypertension (sBP ≥160 mm Hg or dBP ≥110 mm Hg, or both). We classified women according to the maximum blood pressure category reached across all visits for the primary analyses. The primary outcome was a maternal, fetal, or neonatal mortality or morbidity composite. We estimated dose-response relationships between blood pressure category and adverse outcomes, as well as diagnostic test properties.FindingsBetween Nov 1, 2014, and Feb 28, 2017, 21 069 women (6067 in India, 4163 in Mozambique, and 10 839 in Pakistan) contributed 103 679 blood pressure measurements across the three CLIP trials. Only women with non-severe or severe stage 2 hypertension, as discrete diagnostic categories, experienced more adverse outcomes than women with normal blood pressure (risk ratios 1·29–5·88). Using blood pressure categories as diagnostic thresholds (women with blood pressure within the category or any higher category vs those with blood pressure in any lower category), dose-response relationships were observed between increasing thresholds and adverse outcomes, but likelihood ratios were informative only for severe stage 2 hypertension and maternal CNS events (likelihood ratio 6·36 [95% CI 3·65–11·07]) and perinatal death (5·07 [3·64–7·07]), particularly stillbirth (8·53 [5·63–12·92]).InterpretationIn low-resource settings, neither elevated blood pressure nor stage 1 hypertension were associated with maternal, fetal, or neonatal mortality or morbidity adverse composite outcomes. Only the threshold for severe stage 2 hypertension met diagnostic test performance standards. Current diagnostic thresholds for hypertension in pregnancy should be retained.FundingUniversity of British Columbia, the Bill & Melinda Gates Foundation.

Economic and cost-effectiveness analysis of the Community-Level Interventions for Pre-eclampsia (CLIP) trials in India, Pakistan and Mozambique

BackgroundThe Community-Level Interventions for Pre-eclampsia (CLIP) trials (NCT01911494) in India, Pakistan and Mozambique (February 2014–2017) involved community engagement and task sharing with community health workers for triage and initial treatment...

Pregnancy Outcomes and Blood Pressure Visit-to-Visit Variability and Level in Three Less-Developed Countries.

[Figure: see text].

Role of community engagement in maternal health in rural Pakistan: Findings from the CLIP randomized trial.

BackgroundCommunity-based strategies to promote maternal health can help raise awareness of pregnancy danger signs and preparations for emergencies. The objective of this study was to assess change in birth preparedness and complication readiness (BPCR) and pregnant women’s knowledge about pre-eclampsia as part of community engagement (CE) activities in rural Pakistan during the Community Level Interventions for Pre-eclampsia (CLIP) Trial.MethodsThe CLIP Trial was a cluster randomized controlled trial that aimed to reduce maternal and perinatal morbidity and mortality using CE strategies alongside mobile health-supported care by community health care providers. CE activities engaged pregnant women at their homes and male stakeholders through village meetings in Hyderabad and Matiari in Sindh, Pakistan. These sessions covered pregnancy complications, particularly pre-eclampsia/eclampsia, BPCR and details of the CLIP intervention package. BPCR was assessed using questions related to transport arrangement, permission for care, emergency funds, and choice of facility birth attendant for delivery during quarterly household surveys. Outcomes were assessed via multilevel logistic regression with adjustment for relevant confounders with effects summarized as odds ratios and 95% confidence intervals.ResultsThere were 15 137 home-based CE sessions with pregnant women and families (n = 46 614) and 695 village meetings with male stakeholders (n = 7784) over two years. The composite outcomes for BPCR and pre-eclampsia knowledge did not differ significantly between trial arms. However, CE activities were associated with improved pre-eclampsia knowledge in some areas. Specifically, pregnant women in the intervention clusters were twice as likely to know that seizures could be a complication of pregnancy (odds ratio (OR) = 2.17, 95% confidence interval (CI) = 1.11, 4.23) and 2.5 times more likely to know that high blood pressure is potentially life-threatening during pregnancy (OR = 2.52, 95% CI = 1.31, 4.83) vs control clusters.ConclusionsThe findings suggested that a CE strategy for male and female community stakeholders increased some measures of knowledge regarding complications of pre-eclampsia in low-resource settings. However, the effect of this intervention on long-term health outcomes needs further study.Trial registrationClinical Trials.gov – INCT01911494.

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

To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management. In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization. The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity. We recruited 39,446 women in intervention (N=20,264) and control clusters (N=19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p=0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p=0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p=0·74) or morbidity (1·12 [0·57, 2·16]; p=0·77); early (0·95 [0·82-1·09]; p=0·46) or late neonatal deaths (1·23 [0·97-1·55]; p=0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p=0·40). Improvements in outcome rates were observed with 4-7 (p=0·015) and ≥8 (p<0·001) (vs. 0) CLIP contacts. The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening. The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis

SummaryBackgroundTo overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries.MethodsIn this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014–17. Consenting pregnant women, aged 12–49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564.FindingsOverall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22–30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90–1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.InterpretationThe CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening.FundingUniversity of British Columbia, a grantee of the Bill & Melinda Gates Foundation.

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

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. 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 (<4h) or non-urgently (<24h), 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. 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. 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). As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.

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

Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. 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. The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), 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 CLIP contacts. 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. 15,013 women (15,123 pregnancies) were recruited in intervention (N=7930; 2·0% loss to follow-up (LTFU)) and control (N=7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p=0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p=0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p=0·033). As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).

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

BackgroundTravel 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.ObjectivesThis 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.MethodsWomen 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.ResultsModelled 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]].ConclusionModelling 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

Self-reported maternal morbidity: Results from the community level interventions for pre-eclampsia (CLIP) baseline survey in Sindh, Pakistan.

Community-based data regarding maternal and perinatal morbidity and mortality are scarce in less-developed countries. The aim of the study was to collect representative community-level demographic health information to provide socio-demographic and health outcome data. A retrospective household survey of women of reproductive age (15-49 years) living in two districts of Sindh Province, Pakistan was conducted. Pregnancy incidence over the past 12 months and during each woman's lifetime; maternal, fetal, infant and child deaths in the past 12 months; and rates of hypertension and seizures in pregnancy were calculated. From June to September 2013, 88,410 households were surveyed with 1.2 (±0.6) women of reproductive age per household. 19,584 women (11.9%) reported pregnancies in the preceding 12 months; 83.0% had live births, 3.5% resulting in stillbirths and 13.6% in miscarriages. 34.2% of deliveries occurred at home. Out of all women who reported a pregnancy in past 12 months, 62.1% reported high blood pressure and 11.9% reported seizures complicating her most recent pregnancy. Blood pressure was not measured during survey to confirm hypertension. The perinatal, neonatal and maternal mortality ratios were 64.7/1000, 39/1000 and 166/100,000 livebirths, respectively. This study estimated population-level mortality ratios that can be used for the planning of health interventions in these regions. Self-reported pregnancy hypertension and seizures was inaccurate, reflecting limited community understanding of these disorders. Mortality estimates are comparable to those reported by the World Health Organization for maternal mortality ratio and neonatal mortality rate of 170/100,000 and 36/1000 live births, respectively.

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

BackgroundMost 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 findingsCLIP-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%).ConclusionsPregnancy 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 registrationThis study is a secondary analysis of a clinical trial - ClinicalTrials.gov registration number NCT01911494.

254. Community Level Interventions for Pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial

In Pakistan, an important contributor to maternal, fetal, and neonatal mortality is pregnancy hypertension. Its early detection and initial management may be amenable to task-sharing by Lady Health Workers (LHWs). To reduce by 20%, one or more of: maternal death/morbidity, stillbirth, or neonatal death/morbidity in the intervention clusters. The Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised control trial (NCT01911494) recruited pregnant women in 20 union councils (clusters) in Sindh Province. The CLIP intervention (10 clusters) consisted of community engagement and LHW-provided mobile health-guided clinical assessment and initial treatment (MgSO4 or methyldopa, as appropriate), and referral by LHWs to facility for further management. Data were collected by quarterly household survey. Treatment effect was estimated by multi-level logistic regression modeling, adjusting for baseline cluster- and individual-level variables of prognostic significance. A priori defined secondary analyses included evaluation of temporal and dose-dependent treatment effects. Of 39,444 women recruited (20,264 women intervention, 19,180 control), losses to follow-up were 3·7% and 4·5%, respectively. The primary outcome did not differ between arms (N = 5381 women, 26·6% vs. N = 4195, 21·9%); adjusted odds ratio (aOR) 1·20, 95% confidence interval (CI) [0·84–1 72]. In both arms, an estimated reduction in the odds of primary outcome of 7.0% per quarter was observed (OR = 0.93, 95% CI 0.93,0.94, p < 0.001). In the intervention arm, the temporal trend-adjusted primary outcome rate decreased by 8.0% (aOR = 0.92 [0.90–0.95], p < 0.001) for each CLIP visit beyond three. While there was no difference in the primary outcome in intervention vs. control clusters, outcomes improved over time in all clusters, particularly maternal morbidity; suggesting that quarterly household surveillance served as an intervention. Receipt of more than three CLIP visits was associated with fewer adverse outcomes, suggesting a possible threshold of intervention that must be delivered to achieve positive health outcomes.