A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial

Complications during labor and delivery are responsible for half the maternal deaths, one-third of stillbirths and a quarter of neonatal deaths occurring each year worldwide [1‐8]. These complications, for example, prolonged labor, preeclampsia, infection and hemorrhage, also cause a substantial amount of maternal morbidity and stillbirths and contribute to neonatal mortality and long-term disability [1, 2, 6]. Antenatal assessment often fails to predict which women will have complications and when these will occur. Their effective management often necessitates urgent, facility-based management of labor by a skilled birth attendant with the ability to provide parenteral medications, carry out procedures, including blood transfusions and cesarean sections, and provide newborn care/resuscitation [4]. However, health care systems in many developing countries struggle to provide skilled attendance and necessary emergency obstetric care [9, 10].

Sixty million births per year world-wide currently occur outside facilities, usually without skilled attendance [10]. When an obstetric emergency occurs, women delivering in these settings are at high risk of poor outcomes due to lack of appropriate services. Attempts to reduce perinatal deaths generally focus on medical treatments, community-participatory approaches or health system interventions [5, 11‐13]. Programs have used various combinations of these interventions [14‐22]; however, simultaneous integration of these strategies has not been adequately evaluated to determine whether in aggregate they would reduce perinatal deaths.

A brief discussion of justification for including specific components in our intervention package follows. 1) Community participatory approaches have suggested reductions in maternal/neonatal mortality in Bolivia, India, Bangladesh and Nepal [18‐22]. Changing behavior of families and communities during pregnancy and reducing barriers to health service by addressing context-specific delays (for example, birth preparedness, availability of funds, transport mechanisms) have the potential to improve outcomes in populations where most deliveries occur at home or in primary health facilities [23]. 2) Traditional birth attendants (TBAs) remain a major provider of delivery care, especially in settings where mortality rates are highest [24]. Despite the lack of evidence supporting TBA training as a single intervention to reduce mortality [25], some research supports the inclusion of TBAs within an improved health care system focusing on early recognition of obstetric complications and appropriate referral to obstetric care facilities [13‐15]. The Global Network’s FIRST BREATH Trial, in which all birth attendants, including TBAs, were taught the World Health Organization’s essential newborn care with emphasis on neonatal resuscitation, suggested a reduction of perinatal mortality associated with this training [26]. 3) Finally, facilities in settings with the worst outcomes are often unable to appropriately implement emergency obstetric and neonatal care packages. Efforts to improve quality of care have focused on in-service training, obstetric simulations/drills or perinatal death audits to improve quality and institute solutions for problems that caused fatalities [27].

This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the limited access to quality obstetric and neonatal care leading to a reduction in perinatal mortality in intervention compared to control locations. These teams worked with their communities and the existing health system to implement a broad package of interventions including community mobilization to establish and sustain mechanisms of transport and payment; training to recognize obstetric emergencies and stabilization and appropriate referral for women delivering at home or in first level care facilities; and improvement of quality of care in existing health facilities.

A total of 106 clusters, ranging from 6 in Argentina to 24 in Pakistan, were randomized, with 53 in each treatment group (Figure 2). A total of 70,351 pregnant women were screened in the intervention clusters and 66,830 in the control clusters; of these, 59,189 (84%) and 57,929 (87%) women were eligible and consented in the intervention and control groups, respectively. Those women excluded, for the most part, did not reside in the cluster for a full four weeks prior to delivery. An additional 3,139 (4.5%) and 2,862 (4.3%) deliveries in intervention and control clusters were excluded at delivery due to missing data or other ineligibility criteria. Outcomes were obtained for >99% of eligible women at six-weeks post-delivery (55,712 and 54,822 in the intervention and control clusters, respectively).

Demographic characteristics of the intervention and control participants are shown in Table 2. Overall, almost one-third of women had no formal schooling and 5% had university-level education. Approximately 12% of the mothers were <20 years of age and 83% were 20 to 35 years old. In both groups, about 30% of the women were primiparous; over 12% had more than four prior pregnancies. Table 2 also shows the birthweight, gestational age, and gender distributions. Although there were small differences, none were statistically significant at P <0.05.

Table 3 shows the number of interventions applied in the treatment clusters by site, emphasizing the great amount of work done by the site and cluster teams. The 53 intervention cluster teams (one per cluster) led more than 50,000 cluster-level activities, including meetings, trainings and other community sensitization activities. The specific activities included facility training (n = 1,309), HBLSS training (n = 26,623), community mobilization training (n = 21,060) and other meetings (n = 1,441). There were a total of 304 facility reviews; on average, each facility was reviewed more than four times during the trial. There were 5,039 facility death audits. In each site, more death audits were completed than there were study deaths because facility audits included deaths of women and their newborns from non-study areas. Village-level core groups went through the community action cycle stages (organize, explore, plan, act and evaluate) generally in sequential order; however, due to occasional division of one into two core groups, a few appear to start the sequence at mid-cycle. The primary issues identified during these activities were difficulty recognizing that the mother/baby had a problem requiring treatment, lack of transportation and lack of funds to pay for facility care (data not shown). Altogether, 96.7% of the village-level core groups reached the act stage by the end of the trial. Using these data and the a priori criteria for implementing the intervention, 37.7% of the clusters met two or fewer criteria, 32.1% of the clusters met three criteria, and 30.2% met all four criteria.

Table 4 summarizes the indicators of the antenatal and delivery care by intervention and control groups after the trial’s initiation. In both arms, almost 60% of women attended at least one antenatal class. More than three-fifths of women in both groups reported having access to emergency transport, if necessary, for delivery, and the rate of facility delivery in both groups was 65%. In the intervention group, 61.3% of women reported access to emergency funds in case a facility delivery was needed, compared to 56.8% in the control group and 87.1% of women in the intervention group had identified a birth attendant prior to delivery compared to 84.6% in the control group. However, neither of these differences rose to statistical significance.

Table 5 first shows the primary outcome of perinatal mortality and the secondary outcomes for the 18 to 24 months of the intervention. In both the intervention and the control clusters, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). None of the secondary outcomes differed significantly between groups. Next, to determine whether differences developed only late in the project, we evaluated each outcome in the last six months of the intervention. No significant differences in outcome emerged. Finally, we examined the primary outcomes for intervention compared to control clusters in the 12 months post-trial and found no significant differences in any outcome measure. We also compared the outcomes in the better performing intervention clusters to their controls for the entire intervention time period, and for the last six months of the intervention (Table 6). There were no significant differences in outcomes in either time period.

In geographic areas with high maternal and perinatal mortality in seven sites in six countries, we found that a multipronged intervention that included: 1) community mobilization and birth attendant education focusing on birth planning and transportation to a hospital; 2) birth attendant recognition of complications, stabilization and appropriate, timely referral to a hospital; and 3) hospital staff training focusing on appropriate and timely management of medical complications did not reduce perinatal mortality.

We have considered the potential reasons why our efforts did not achieve the hypothesized outcomes. One possibility is that we had the right group of interventions to achieve an important improvement in outcomes, but that the intervention was not carried out sufficiently well in enough clusters to impact either the process measures or the outcomes. However, based on our ongoing monitoring systems, we documented that the intervention components were generally implemented with high fidelity. The very large number of activities documented plus the fact that there was no improvement in outcomes even among the best performing clusters, suggests this was not the case. Another possibility is that our chosen package of interventions was not implementable with the resources or time allowed for this project. However, substantial resources were allocated to the intervention (each study site had a budget over the two years of approximately $500,000 USD or on average about $60,000 USD per intervention cluster) and many of the clusters achieved substantial compliance in most components of the intervention. That there were no observable improvements in outcome in the final six months of the intervention or even in the year after the intervention ceased, suggests that insufficient time was not responsible for the lack of observed improvement in outcome. Another possibility is that although we had three intervention components, most sites appeared to give more attention to community mobilization and community birth attendant training and less to hospital staff training. Since a well-functioning hospital and a trained, motivated staff seem crucial for achieving the level of mortality reduction hoped for in this study, it may be that hospital training was insufficient. However, a substantial amount of hospital training occurred, and potential areas for improvement were made apparent to the hospital administrators and staff by the facility and mortality audits.

A more likely explanation for the lack of improvement in outcomes in the intervention clusters is that the deficiencies in the health systems were beyond potential improvement by our package of interventions. Without appropriate complementary efforts by the ministries of health or other agencies to strengthen the health care infrastructure at referral facilities to ensure availability of skilled personnel and access to comprehensive emergency obstetric care including appropriate essential medications, supplies, and equipment, it is likely that interventions predominantly focusing on community mobilization and birth attendant training alone are insufficient to achieve the hoped-for results [22‐25, 29]. Community mobilization or birth attendant training might only help to reduce mortality beyond a certain level if there is a concurrent improvement in the capacity for managing obstetric and neonatal emergencies. Our study suggests that the weaknesses of the delivering facilities and health systems in the participating sites, including the lack of essential medications, supplies and equipment, were not adequately addressed by the three-pronged strategy used in this trial [29].

This study had a number of strengths including the participation of seven sites in six countries and the large number of clusters. The populations in the intervention and the control arms were similar. A further strength is that the study was performed in locations which had ongoing pregnancy registries with excellent follow-up of mothers and infants, and with registry personnel distinct from trial staff, reducing potential for bias. That data collection continued for a full year after the intervention ceased is a further strength. A potential weakness was that all the clusters did not achieve complete implementation, although a substantial amount of work was done in every cluster. Another potential weakness was that because the intervention could not be blinded, some of the control clusters may have adopted a portion of the trial interventions. We do not think that contamination occurred frequently, but cannot rule out this possibility.

Our results are of major public health importance. First, rolling out programs similar to the one tested here without formal testing of their effectiveness will not help to improve pregnancy-related outcomes nor achieve progress toward Millennium Development Goals 4 and 5 to reduce maternal and child mortality. Second, we believe that substantial attention to creating a system of maternal and neonatal care with adequate supplies and infrastructure, in addition to training of existing personnel, is needed to achieve substantial improvements in pregnancy outcomes - specifically systems that include appropriate access to delivery facilities for all women, facilities with sufficient equipment and access to essential medications, and especially a well-trained and motivated staff with a high degree of skill in treating obstetric and neonatal emergencies. Our results suggest that in many low-resource settings, it may take substantial resources and time to create a sustainable and functioning maternal and newborn care system to accomplish this goal than were available for the current project.