Safe Birth Kits: Promise Unfulfilled? Evidence From A Randomized Trial In Northern Nigeria

Over the last twenty years, progress in enhancing health outcomes for pregnant women and newborns in developing countries has remained slow. Data from the World Health Organization suggests more than 300,000 women die each year from complications in pregnancy and childbirth, while more than two million newborns die within the first month of life (WHO 2018). These challenges are particularly acute in sub-Saharan Africa, a region that accounts for more than half of maternal and newborn deaths.

The WHO estimates that 10.7% of maternal deaths (Say et al. 2014) and 30% of newborn deaths are due to infections contracted during birth (WHO 1994). However, the risk of such infection can be minimized via the appropriate use of hygienic practices, often summarized as the “six cleans”: clean hands, a clean perineum, a clean delivery surface, a clean cord and tying instruments, and a clean cloth for drying (Khan et al. 2007, Lawn et al. 2006).

For deliveries that occur outside of facilities, or in facilities that lack access to sterile equipment, stakeholders have promoted birth kits (also known as safe delivery kits or clean delivery kits) as a promising intervention targeting the risk of infection and sepsis. Birth kits, comprising a package of sterile materials including a plastic sheet, soap, sterile liquid, a razor blade, cotton wool, gloves, and string, are low-cost and relatively easy to deliver in challenging and low-resource contexts. However, there is limited high-quality evidence around the impact of this intervention on health outcomes

A recent secondary analysis of data from a cluster randomized controlled trial conducted in Jigawa state, Nigeria – a region characterized by one of the world’s worst maternal mortality rates (Sharma et al. 2017), and affected by ongoing conflict linked to the Boko Haram rebellion – suggests that an intervention in which safe birth kits were distributed to women at home was not associated with any reduction in maternal or infant morbidity or mortality. Jigawa is characterized by generally low rates of maternal health services utilization and poor baseline health outcomes, including the third lowest rate of facility-based delivery among Nigerian states (6.7% vs 35.5% nationally), and the fourth lowest percentage of fully vaccinated children 12-23 months of age (4% vs 25% nationally). In addition, only 11% of women in Jigawa are literate (NPC 2014).

In this evaluation, communities were randomly assigned to one of four experimental arms; in the three intervention arms, health educators deemed community resource persons or CoRPs conducted home visits with pregnant women, encouraging them to utilize health facilities for maternal health services and providing additional health information. In addition, in one intervention arm, the CORPs distributed safe birth kits directly to all pregnant women in their second and third trimesters.

Baseline, post-birth and endline data related to 3,317 births observed over a period of three years in 72 intervention communities in Jigawa state, Nigeria, were analyzed using hierarchical, logistic regression models. In this sample, 140 women received birth kits, and 72 women used the kits; thus the intervention was characterized by relatively low coverage rates among the sample of eligible pregnant women. However, there is no evidence of systematic targeting of birth kit distribution by the CORPs, as there were no associations between baseline demographic characteristics, health history, and knowledge and attitudes and receipt of a kit.

Relative to non-users, women who used birth kits reported reduced odds of past pregnancy complications (OR=0.44, 95% CI: 0.19-1.00) as well as significantly higher odds of feeling generally healthy at baseline (OR=2.00, 95% CI: 1.06-3.76), of exposure to radio media (OR=1.97, 95% CI: 1.21-3.22), and of perceiving themselves as having a low-risk pregnancy (OR=3.05, 95% CI:1.39-6.68). This suggests that ceteris paribus, women who used the birth kits were characterized by better health at baseline. However, women who used a kit exhibited significantly lower odds of completing four or more ANC visits (adjusted OR=0.39, 95% CI: 0.18-0.85) and significantly higher odds of reporting prolonged labor (adjusted OR=4.75, 95% CI: 1.36-16.59), and post-partum bleeding (adjusted OR=3.25, 95% CI: 1.11-9.52). There was no association between kit use and facility-based delivery or postnatal care. Thus, our findings provide no evidence of enhanced health outcomes, and some evidence of increased health risks for kit users in this setting.

The evidence presented here suggests two key conclusions. First, use of birth kits was relatively low in a low-income, low-education population characterized by minimal baseline utilization of maternal health services. Second, the provision of birth kits was not associated with any reduction in maternal or neonatal morbidity or mortality. This highlights the need for additional research exploring whether safe delivery kits can be appropriately and safely used – and generate any enhancement in health outcomes – when distributed outside of the formal health system.

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