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Background: Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods: A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results: Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions: Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration: The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.
The trial protocol has been published previously [29] and the trial was retrospectively registered on 3rd October 2017 with Clinical Trials (trial identifier: NCT0329949). The trial was conducted within Gomma, Seka Chekorsa and Kersa districts in Jimma Zone, Oromiya region (Fig. 1). Together, the districts had about 153,000 households in 2015/2016 [30]. Jimma town situated roughly in the centre of the three districts is about 350 km from the capital, Addis Ababa. Map of study districts depicting locations of health centres and Jimma Town (created using ArcMap version 10.6.1 Redlands, CA: Environmental Systems Research Institute, Inc.) Women typically receive maternal healthcare services at primary health care unit (PHCU) level; PHCUs comprise a health centre and satellite health posts that are each operated by community-based health extension workers (HEWs). Health posts serve populations of up to 5000 by providing preventive and basic curative services. Jimma Zone has eight hospitals, 122 health centres and 566 health posts [31]. HEWs function as important links between the community and the health system by referring women to health centres for antenatal and obstetric care and providing follow up postnatal care (PNC). They are often supported by the Women’s Development Army (WDA) whose members are women regarded as leaders in their communities for successfully adopting the health and sanitation guidelines outlined in the Health Extension Program packages [32]. Health centres are usually staffed with clinical officers and midwives; in 2016, 21 of the 24 study health centres had one or two midwives trained in basic emergency obstetric care (BEmOC) [30]. A pragmatic, three-arm, stratified, cluster-randomized trial design was used to evaluate the effect of upgraded, functional MWHs (MWH+) and leader training on the primary outcome of institutional births. The trial arms consisted of: (i) upgraded MWH+ combined with religious and community leader training (“local leader training”) around safe motherhood strategies to mobilize communities; (ii) local leader training alone; and, (iii) usual care. PHCU catchment areas served as clusters, were randomized to trial arms, and were the level at which the interventions were delivered. PHCUs were eligible to participate in the trial if maternity waiting services were available at the health centre. Women of reproductive age who reported a pregnancy outcome (livebirth, stillbirth, induced or spontaneous abortion) 12 months prior to each round of survey were eligible for inclusion in cross-sectional surveys at baseline and 21 months post intervention roll-out [29]. Women who experienced induced/spontaneous abortions were not excluded as they could benefit from the leader training intervention activities and seek maternal healthcare services. In order to detect an absolute difference in the proportion of institutional births of 0.17 with 80% power, 24 clusters with 160 women each (assuming equal cluster sizes) were required for each round of surveys. This assumed a control arm proportion of 0.4 and used a two-sided alpha of 0.025 to account for two pairwise comparisons [29]. Using the method described by Hooper and Bourke, the product of two design effects were used to inflate the sample size required under a similarly powered individually randomized design. The first design effect, due to cluster randomization, was calculated using a within-period intracluster correlation coefficient (ICC) of 0.1 [33]; the second design effect, due to repeated assessments, was calculated using the within-period ICC and a cluster autocorrelation coefficient of 0.8 which allowed for a 20% decay in strength of the ICC among women surveyed in different time periods [34]. To ensure a balanced distribution of poorly functioning MWHs and health centres with low capacity to provide BEmOC, stratified randomization was used as described previously [29]. Briefly, using 2016 Jimma Zone Health Office (JZHO) data on MWH functionality, MWHs were classified as high functioning (≥ 5 service indicators present) or low functioning (< 5 service indicators present). BEmOC capacity was classed as high (≥5 of the 7 signal functions present) or low (< 5 signal functions present). Clusters were grouped into the four strata that resulted and a random number generator in STATA was used to create the allocation sequence [26]. The allocation sequence was made known to the study coordinator in May 2017 when distribution of MWH supplies to intervention sites began; this was also when health centre staff at MWH + leader training sites were made aware of their allocation status. Data collectors identified randomly pre-selected households, screened women for eligibility, provided information (survey objectives, institutions involved, expectations from participants, participant rights, and risks and benefits of participating), answered questions and took verbal consent from women wishing to be interviewed. About 4% of women interviewed at endline were also interviewed during baseline as no exclusions were made based on prior participation. The level of existing services is described in the trial protocol [29]. Briefly, MWHs are modelled as government-community partnerships and rely on cash or in-kind contributions from the community for construction and operation. There was considerable variation in quality across the MWHs in the study area. In 2016, 16 of the 24 waiting facilities were poorly functioning lacking basic items such as bedding, cooking utensils, a reliable water supply or electricity [30]. Women generally depend on HEW or midwives referrals to access MWHs and referral practices differed between sites. HEWs are mostly responsible for conducting health promotion activities within the community and are aided by the WDA. Religious leaders are acknowledged to be influential members of the community and formative work revealed that they consider promoting access to maternal healthcare services and providing support to pregnant women part of their role [35]. However, there is little evidence of how widespread or consistent efforts by religious leaders are to promote institutional births and/or use of MWHs in the study districts. The MWH+ intervention component entailed upgrading and standardizing existing waiting facilities based on minimum needs identified through formative evaluation [29] and guided by the national policy [16] to create a home-like environment for pregnant users. MWHs situated at health centres in intervention arms were equipped with bedding, utensils and personal hygiene items, solar lamps, water tanks, drinking water purifiers, cooking stoves and cleaning items. Supplies were transported to intervention sites under the auspices of the district health offices. Remuneration for an MWH attendant to cook and clean was also provided. A register was also introduced to better track users [29]. In order to avoid disrupting the community contribution systems used to support MWHs particularly with food provision, no meals were supplied through the study. During the first month after supply distribution, the study coordinator visited intervention sites to ensure appropriate setup of materials at the MWHs and to brief midwives on correct completion of the MWH register placed at interventions MWHs. However, after this time supportive supervision visits were part of the agreed-upon role of the Jimma Zone Health Office and the District Health Offices. This strategy was employed to test out and facilitate sustainable mechanisms of MWH operation. In recognition of the fact that women’s social environments are as important in influencing use of maternal healthcare services [36, 37] as individual-level factors such as education [38, 39] and service quality, the local leader training intervention component was created. HEWs, religious leaders and community leaders (members of the WDA) attended workshops that facilitated identification of access barriers to maternal healthcare services. HEWs were all women with at least a secondary school education and were between 20 and 30 years of age. WDA members generally reflected the demographic profile of women in the community. Religious leaders from the two major religious groups in the area (Christian and Muslim) were mostly male, had completed some level of primary school and were between 30 and 50 years of age. Building on their experiences, participants were encouraged to identify strategies to support their communities in overcoming these barriers to make motherhood safer and to promote use of antenatal care, MWHs, delivery care at facilities and postnatal care. Due to the pragmatic nature of the trial, the commitment to community empowerment and establishment of sustainable practices, leaders were encouraged to create activities they felt were optimal for their communities. Positive strategies used to improve access to services identified through formative research (such as urging women’s social networks to assist with childcare and domestic chores, encouraging family and friends to accompany pregnant women to health facilities or working together to organize transport for women) [35] were discussed during training as part of brainstorming locally suited strategies for leaders to promote. HEWs committed to co-facilitating the WDA workshops, revamping pregnant women conferences to discuss safe motherhood and use of MWHs with women and collaborating with religious leaders to improve community contributions to MWHs. Religious leaders opted to address safe motherhood strategies during their religious gatherings and attend any community events organized by HEWs and WDAs to promote use of maternal healthcare services or tackle access challenges faced by the community. Data collectors were blind to women’s allocation status during both baseline and endline assessments. It was not possible to blind women or healthcare providers to intervention status but both groups were unaware of the study hypotheses. Figure 2 outlines the trial processes depicting order of participant recruitment, randomization, intervention delivery and outcome assessments; blinding status is indicated using black for complete blinding and grey for partial blinding. This timeline cluster tool is recommended for assessing risk of bias in cluster randomised trials [40]. Timeline cluster diagram illustrating participant recruitment, randomization, outcome assessments and blinding status of the trial Identification and recruitment of clusters as well as identification of women for the baseline survey occurred prior to randomization, making identification bias unlikely. Once MWHs upgrading was completed and leader activities commenced, providers (health centre staff, HEWs) and participants (women) across the study area may have been aware of their cluster’s allocation status depending on the extent of their interaction with health centres and each other. The risk of contamination through leaders in the control arm encouraging their congregation to deliver at health facilities, as well as performance bias from being aware of allocation to the intervention arms cannot be precluded. The primary outcome was institutional birth defined as delivery of the last child at a health facility where obstetric care is provided (i.e health centre or hospital) as reported by an enrolled woman. Secondary outcomes included antenatal care (self-reported antenatal care received for last child delivered) and postnatal care (self-reported postnatal care received for last child delivered within 48 h and 6 weeks). Outcomes were measured at baseline and 21 months after the introduction of interventions (“endline”) through household surveys. Data were collected using interviewer-administered questionnaires in Afaan Oromo or Amharic which contained sections on socio-demographics, reproductive history, attitudes towards and use of maternal health care service use including MWHs, danger sign knowledge and social support. The questionnaire was adapted based on the Ethiopia Demographic Health Survey [41] and the JHPIEGO birth preparedness and complication readiness monitoring tool kit [42]; the MWH module was developed by the research team. (Supplement 1). The protocol specified that endline data collection would take place 24 months after the introduction of the interventions. However, due to delays in intervention rollout experienced due to political instability in the country, endline outcomes were assessed after a shorter duration of intervention exposure. Similarly, resource and time constraints necessitated the cancellation of an additional round of data collection (midline survey). This resulted in the need to increase the minimum absolute detectable difference in institutional births from 15% as planned, to 17% to maintain prespecified sample size and power. An intention to treat approach was used for primary analysis where original cluster assignments to trial arms were maintained regardless of whether interventions were delivered or not. Institutional births were compared at endline between intervention and control groups using a generalized linear mixed model. The model included a random intercept for PHCU to account for within-period ICC as well as a random cluster-period effect to account for the between-period ICC [34]. Differences at baseline were constrained by including fixed effects for time and intervention by time. The Kenward-Roger degrees of freedom approximation was used to account for bias due to the relatively small number of clusters included in the trial [43]. Secondary outcomes, namely postintervention antenatal care and postnatal care use, were analysed as described for the primary outcome. Odds ratios with 97.5% confidence intervals (two-sided alpha of 0.025 used) were used to report comparisons between intervention groups and control. The ICCs for outcomes were calculated on the proportions scale. Data analysis was conducted in STATA version 15 and SAS version 9.4. Although not specified in the trial protocol, frequency tables, descriptive statistics and graphs were generated to contextualize the findings on the impact of the interventions on institutional births. The intervention components were expected to increase the levels of institutional births by improving awareness and use of functional MWHs and enhancing women’s access to facility obstetric care by mobilizing community support in tackling barriers. Thus, four main areas were explored: (i) awareness of MWHs (ii) appropriate linkage of women to MWHs (iii) use of MWHs and obstetric services and (iv) quality of MWH services as part of ancillary analyses.
