Background

Oral misoprostol, administered by trained health-workers is effective and safe for preventing postpartum haemorrhage (PPH). There is interest in expanding administration of misoprostol by non-health workers, including task-shifting to pregnant women themselves. However, the use of misoprostol for preventing PPH in home-births remains controversial, due to the limited evidence to support self-administration or leaving it in the hands of non-health workers. This study aimed to determine if antenatally distributing misoprostol to pregnant women to self-administer at home birth reduces PPH.
Methods

Between February 2013 and March 2014, we conducted a stepped-wedge cluster-randomized trial in six health facilities in Central Uganda. Women at 28+ weeks of gestation attending antenatal care were eligible. Women in the control-arm received the standard-of-care; while the intervention-arm were offered 600mcg of misoprostol to swallow immediately after birth of baby, when oxytocin was not available. The primary outcome (PPH) was a drop in postpartum maternal haemoglobin (Hb) by =?2g/dl, lower than the prenatal Hb. Analysis was by intention-to-treat at the cluster level and we used a paired t-tests to assess whether the mean difference between the control and intervention groups was statistically significant.
Results

97?% (2466/2545) of eligible women consented to participate; 1430 and 1036 in the control and intervention arms respectively. Two thousand fifty-seven of the participants were successfully followed up and 271?(13.2?%) delivered outside a health facility. There was no significant difference between the study group in number of women who received a uterotonic at birth (control 80.4?% vs intervention 91.4?%, mean difference?=?-11.0?%, 95?% confidence interval [CI] -25.7?% to 3.6?%, p?=?0.11). No woman took misoprostol before their baby’s birth. Shivering and fever were 14.9?% in the control arm compared to 22.2?% in the intervention arm (mean difference?=?-7.2?%, 95?%?CI -11.1?% to -3.7?%), p?=?0.005). There was a slight, but non-significant, reduction in the percentage of women with Hb drop =?2g/dl from 18.5% in the control arm to 11.4?% in the intervention arm (mean difference?=?7.1?%, 95?%?CI -3.1?% to 17.3?%, p?=?0.14). Similarly, there was no significant difference between the groups in the primary outcome in the women who delivered at home (control 9.6?% vs intervention 14.5?%, mean difference -4.9; 95?% CI -12.7 to 2.9), p?=?0.17).