Abstract
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
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.
Trial Registration
ISRCTN 86264432 (DOI 10.1186/
ISRCTN86264432
).