Community-based mentoring to reduce maternal and perinatal mortality in adolescent pregnancies in Sierra Leone (2YoungLives): a pilot cluster-randomised controlled trial.

Background: Sierra Leone has very high maternal and neonatal mortality rates, and a large proportion of these deaths occur in adolescents, a particularly vulnerable group, and is usually driven by poverty, lack of education, and sparse employment opportunities. We evaluated the feasibility and potential effects of a community-based mentoring intervention from pregnancy up to 1 year after birth to inform a subsequent larger trial aiming to reduce mortality among adolescent girls and their newborns (2YoungLives).

Methods: We conducted a parallel-arm, pilot, hybrid implementation-effectiveness cluster randomised controlled trial of the introduction of the 2YoungLives intervention as an adjunct to maternity care in rural and urban communities served by 12 peripheral health units in five districts of Sierra Leone. Clusters were randomly allocated 1:1. All pregnant adolescent girls aged younger than 18 years living in those cluster communities and presenting for maternity care were eligible. The primary outcome was a composite of maternal and perinatal deaths (including stillbirths and neonatal deaths), assessed in all randomly allocated participants who remained in follow-up. The trial was prospectively registered (ISRCTN32414369).

Findings: Between July 4, 2022, and Nov 30, 2023, 673 girls were included in the trial; six clusters with 372 girls were allocated to 2YoungLives (intervention group; 361 included in primary analysis) and six clusters with 301 girls were allocated to the control group (279 included in primary analysis). Loss to follow-up accounted for less than 10% in both groups. The incidence of the primary composite outcome by intention to treat was significantly lower in the intervention group (23 [6%] of 361 compared with 35 [13%] of 279 in the control group [adjusted risk ratio 0·52, 95% CI 0·34 to 0·81, p=0·0034; risk difference -0·05%, 95% CI -0·10 to -0·01]). The number needed to treat with 2YoungLives to prevent one maternal or perinatal death was 18 (95% CI 10 to 92).

Interpretation: 2YoungLives, a community-based mentoring intervention for adolescent girls from pregnancy up to 1 year after birth, was feasible to implement in urban and rural communities in Sierra Leone and significantly reduced a composite of maternal deaths, stillbirths and neonatal deaths.

Funding: UK National Institute for Health and Care Research.