Zambian infants delivered by traditional birth attendants who had been trained to manage several perinatal conditions were nearly half as likely to die during their first month of life than infants delivered by control traditional birth attendants who received no such training. This equated to one death averted for every 56 deliveries attended by an intervention birth attendant (number needed to treat), or an absolute reduction of about 18 deaths per 1000 live births. Putting this in context, in 2007 the countrywide neonatal mortality rate in Zambia was 34 per 1000 live births.21
We observed no difference in the proportion of stillborn infants between the two groups—an important internal control, since the study interventions should have had no effect on stillbirth rates.
Although our primary end point was all cause mortality by day 28, and reflected the combined effects of the neonatal resuscitation protocol and use of antibiotics with facilitated referral, training in the resuscitation protocol seems to have been the most effective component of the study interventions. Despite a steep increase in referrals to health centres by intervention birth attendants, and the predominance of amoxicillin use during the first week after delivery, when most of the deaths occurred, the verbal autopsy data did not suggest a significant reduction in deaths from serious infections. By contrast, deaths attributed to asphyxia were about 70% less common among infants delivered by intervention birth attendants. Given recent estimates that around 800
000 infants die each year worldwide as a result of birth asphyxia, these findings have broad public health relevance.2 11
Although the effectiveness of the intervention using antibiotics with facilitated referral was less apparent than for the neonatal resuscitation protocol, the higher frequency of referrals to health centres by the intervention birth attendants was an important secondary benefit of the intervention. This is important when traditional birth attendants are viewed as the final stage in an extended healthcare system. In Lufwanyama, traditional birth attendants are an important link between a highly dispersed rural community and the rural health centres, and this link seemed to be strengthened by the intervention to train the birth attendants. This reinforces the need to improve the capacity of rural health centres to care effectively for children with serious infections. In the present study, the intervention using single dose amoxicillin with facilitated referral was not expected to be curative, but rather was hoped to help bridge the transition to a higher level of care—hence the importance of coupling provision of antibiotics with facilitated referral. Unfortunately, the Lufwanyama health centres often could not offer more definitive care, and this might partially explain why the antibiotics with facilitated referral did not show a greater benefit.
Strengths and limitations of the study
Key strengths of the study were its cluster randomised design, which distributed the intervention skills within the context of an existing healthcare system; the intensity and frequency of the intervention training, which gave us confidence that the intervention skills were actually being acquired and retained; and our data collection system using data collectors embedded within the communities and in regular contact with the birth attendants. Because the data collectors also tracked the pregnant women followed by each birth attendant, we were confident that all births were accounted for. Additionally, the study had low rates of loss to follow-up (about 2%). Even assuming that all of these losses represented unrecorded deaths, our sensitivity analysis showed that our study conclusions would not have changed.
Several study limitations merit discussion. Firstly, we were unable to observe directly any of the deliveries, forcing us to rely on the birth attendants’ delivery records for details of how the neonatal resuscitation protocol was being implemented. However, the study operated across a physically vast area (nearly 10
), with the birth attendants carrying out deliveries at mothers’ homes. Hence this was an unavoidable consequence of the study design and acceptable in the context of a field effectiveness trial. Moreover, this limitation had no bearing on the primary end point, which rested on information gathered by the data collectors.
Secondly, the relative contribution of the neonatal resuscitation protocol compared with antibiotics with facilitated referral to the overall reduction in mortality was inferred from indirect evidence, including reports from the birth attendants that the resuscitation protocol steps were used in nearly all deliveries, the timing of the deaths, and the verbal autopsy findings. A more definitive assessment of the impact of each component would require a larger study, powered to assess each component independently. Similarly, the study was designed to measure the overall effect of the interventions on mortality. It was not possible, for example, to disaggregate the components of the neonatal resuscitation protocol to assess the effectiveness of each step in the algorithm separately. Although we have shown that the intervention birth attendants reported correctly using the steps of the resuscitation protocol, particularly the early steps of drying, warming, suctioning, and stimulating, at higher rates than the control birth attendants, we have not attempted to draw inferences about which of these steps was chiefly responsible for the overall effect. In fact, our assumption is that the effectiveness of the neonatal resuscitation protocol derives from the complete package of interventions, rather than from specific components.
Thirdly, the planned total of 4000 deliveries was not reached because the study funding expired. However, the lower than feared loss to follow-up rate left us with a final sample size that actually exceeded the 3360 we predicted to be sufficient for statistical power, so the impact of this was minimal.
Fourthly, given the nature of the interventions in the context of an effectiveness trial, blinding the birth attendants’ group allocation was clearly impossible. Since the birth attendants interacted in their communities, it is possible that some exchange of knowledge may have occurred from intervention to control birth attendants. Although we have no evidence that this actually occurred, we believe the effect of this would have been minimal for two reasons. Firstly, the intervention requires that a birth attendant not just be trained in the skills, but also have the equipment (masks, suction bulbs, receiving blankets, and amoxicillin tablets) for using those skills. Without these, a control birth attendant would not have been effective. Secondly, the effect of cross contamination of skills would render the control birth attendants more like the intervention ones. This would make it more difficult to measure a difference in birth outcomes between the two groups, and bias our results to the null. Therefore, the direction of this hypothetical bias would actually strengthen our conclusions by rendering them more conservative.
Lastly, our data collection system was limited to assessing births and outcomes for infants delivered by study birth attendants, but could not assess the impact of the interventions on overall community wide neonatal mortality. Nor could we determine whether some deliveries that might otherwise have occurred at health centres were instead being carried out by the study birth attendants. However, our objective was not to advocate for an alternative to health centre based obstetric care, nor to play down the importance of emergency obstetric care as a key intervention for reducing maternal mortality in low resource settings,23 24
rather, our goal was strictly limited to determining whether trained traditional birth attendants can save infants’ lives.
One important consideration is that showing the effectiveness of enhanced training for birth attendants would have been far more difficult if Lufwanyama did not already have an active programme for traditional birth attendants. Before the study, the birth attendants had all completed Lufwanyama District Health Management Team approved training in standardised basic obstetric care and clean delivery, viewed themselves as part of an extended healthcare system, and reported their activities centrally, allowing their activities to be tracked. Thus, the study provides an example of what can be accomplished when building on an existing standard of care.
Comparisons with other studies
Our findings seem to contrast with the recently reported results from the First Breath study, in which teaching the neonatal resuscitation protocol as part of an expanded programme in essential newborn care had little impact on neonatal mortality rates.25
However, the present study differed from First Breath in several important aspects. In First Breath the doctors, midwives, or nurses attended around 40% of deliveries, and a third of deliveries occurred in clinics or hospitals. By contrast, 100% of the deliveries in the present study were carried out by traditional birth attendants and all deliveries occurred in remote villages at mothers’ homes. In that study only the intervention birth attendants had the equipment and training for the neonatal resuscitation protocol and antibiotics with facilitated referral, whereas in First Breath the intervention and control attendants initially all received the same equipment and training, which included resuscitation; at a later stage in the trial, cluster randomisation was used to allocate birth attendants to receive additional training in a neonatal resuscitation protocol. This may account for the somewhat counterintuitive finding in First Breath that bag-mask assisted breathing was used at similar rates by the intervention and control birth attendants (4.2% v
3.6%). This suggests that a much larger gap separated the skill levels of the control and intervention arms in the present study than in First Breath. The difference in neonatal mortality rates in the control arm (21.4 per 1000 live births in First Breath v
40.2 per 1000 live births in the present study) emphasises the dissimilarity between the populations studied. In summary, the two studies dealt with fundamentally different questions, in different populations, using different methods.
Two other recent studies are of relevance. Both were community based cluster randomised effectiveness studies, where the primary outcome was neonatal survival. In both, women’s groups, not traditional birth attendants, provided the interventions. The first, carried out in Nepal, included a comprehensive neonatal resuscitation intervention similar to that used in the present study, and observed a significant 30% reduction in neonatal mortality.26
The second study, carried out in Bangladesh, assessed a large number of antenatal, perinatal, and postnatal interventions, of which one was bag-mask ventilation.27
The study found no significant benefit on mortality. However, the resuscitation intervention was limited to positive pressure ventilation without the other steps in the protocol (drying, warming, suctioning, positioning, and stimulation). Combined, these two studies support the hypothesis that effective neonatal resuscitation cannot simply be limited to positive pressure ventilation but must include the full continuum of early neonatal resuscitation interventions.
Questions for further research
Several questions pertaining to the present study remain unanswered. Firstly, what should be the optimal schedule for retraining traditional birth attendants? The goal of the study was to conclusively show the effectiveness of the interventions, not to compare the efficiency of different training schedules or curriculums. By following a rigorous training and retraining schedule, and requiring that each birth attendant undergo a skills assessment at the end of each training session, we were confident that the birth attendants would perform as intended during actual deliveries. It is possible that less frequent retraining or a less intense curriculum could still be effective. That said, a recent study carried out with a group of Zambian birth attendants, unrelated to the present study, reported a significant loss of neonatal resuscitation protocol skills within as few as six months of a primary training.28
Secondly, is there still a role for traditional birth attendants in the management of neonatal sepsis? Neonatal mortality seemed to be lower in the intervention group during postnatal weeks 2-4, when the neonatal resuscitation protocol would presumably have had minimal impact on survival. This difference was not statistically different, although the much lower death rate during this period left this portion of the analysis underpowered. Recent reports from South Asia in which community health workers and traditional birth attendants significantly reduced neonatal sepsis using injectable gentamicin and oral cotrimoxazole, suggest that a strategy of community based management of neonatal sepsis using traditional birth attendants could also be effective.17 29
Lastly, it would be interesting to understand what drove the imbalance in the proportion of deliveries carried out by intervention and control birth attendants, and to understand better the process by which mothers chose their birth attendant. We hypothesise that this imbalance reflected a relative preference for mothers to select intervention birth attendants when they had a choice. The higher compensations paid by mothers to intervention than to control birth attendants lends support to this explanation. Regardless, it is unlikely that this imbalance would have biased our findings. Although mothers were more likely to choose an intervention birth attendant over a control one, the outcome of any given delivery was unpredictable. A bias would have been created only if there was advance knowledge of the outcome of a future delivery at the time that a mother selected her birth attendant during the antenatal period.
Conclusion and policy implications
In the context of a highly dispersed, rural African community with limited access to healthcare, traditional birth attendants were able to master a set of skills that allowed them to significantly reduce neonatal mortality. This was accomplished in a population of women birth attendants with low rates of formal education and under austere conditions, making this example highly generalisable. We believe that this approach has good potential to be applied in other resource constrained settings.
What is already known on this topic
- In developed countries, the neonatal resuscitation protocol has significantly reduced perinatal mortality
What this study adds
- The neonatal resuscitation protocol was highly effective in the developing world
- Training and equipping Zambian traditional birth attendants to carry out an adapted version of the neonatal resuscitation protocol reduced neonatal mortality by day 28 of life by nearly half
- Traditional birth attendants can be trained to refer infants who appear unwell to health centres for further care, and to administer a dose of oral amoxicillin to the infant before referral