A community-based structured birth planning intervention to increase skilled delivery and decrease neonatal mortality: a cluster randomised controlled trial in Pakistan

Abstract Background: We developed and evaluated a behaviour change intervention to improve health outcomes for pregnant women and neonates in rural Pakistan. Methods: We used a parallel, three-arm, unblinded, cluster randomised controlled trial design. Eligible clusters were upgraded health facilities plus all associated community health workers (CHWs) and catchment populations. Randomisation was by computer program (1:1:1 ratio). All pregnant women were eligible. Control CHWs provided usual care to pregnant women. Arm 1 CHWs provided structured birth planning, including birth preparedness and complication readiness planning, and a voucher allowing free travel to access emergency obstetric/neonatal care. Arm 2 CHWs provided structured planning alone. Co-primary outcomes were skilled (doctors and midwifery-trained cadres) birth attendance and neonatal mortality (NNM) at 28 days. Findings: Between November 2011 to May 2012, respectively in arms 1, 2 and the control 21,317, 19,267 and 18,867 women were recruited, and 21,214, 19,125 and 18,812 were followed-up and analysed. Vouchers were almost never used to reclaim travel costs. Skilled attendance was 64% (12,045/18,812) in the control arm, 72.3% (15,335/21,214) (adjusted odds ratio [aOR] 1.56 [95% CI: 0.93, 2.62; p = 0.21]) in arm 1 and 78.1% (14,944/19,125) (aOR 2.16 [95% CI: 1.29, 3.62; p = 0.007]) in arm 2. NNM was 13.4 (per 1,000 live births) in the control arm, 45 (aOR 2.32 [95% CI: 1.48, 3.63; p < 0.001]) in arm 1 and 16.2 (aOR 1.36 [95% CI: 0.84, 2.21; p = 0.21]) in arm 2. Conclusions: Birth planning had inconsistent effects on skilled attendance and NNM, including apparently negative effects on NNM, with concerns about the quality of midwifery care. However, the control arm and arm 2 NNM was improbably low for this setting, and bias in the outcome may explain the observed differences. The travel voucher was little used.