Abstract

Background: Postpartum Haemorrhage (PPH) still remains a major cause of maternal mortality despite adequate knowledge of its causes and treatment. Oxytocin administration is one of the major components of active management of third stage of labour (AMTSL). Evidence suggest benefit of misoprostol as an adjunct however optimal dose is yet to be determine considering the dose depended side effect profile of misoprostol. . Objective: This study evaluated the efficacy and side effect profile of 200µg versus 400µg of prophylactic sublingual misoprostol as adjunct to AMTSL among parturient at risk for PPH. Methods: This was a double blinded, single centre, randomized controlled trial involving two hundred and forty parturient with 2.1% drop out rate , thus 235 of them were analyzed; 117 (48.8%) and 118(49.2%) for 200 and 400 microgram group respectively. Data was analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± 2SD), while categorical variables were presented as numbers and percentages. Chi-square test (X2) was used for comparison between groups for qualitative variables while t-test was used for comparison between groups for quantitative variables. A difference with a P value <0.05 was considered statistically significant. Results: The mean blood loss was similar between the 200µg and 400µg groups of the study with 280.68±179.40mls and 253.86±169.80mls for the 200µg and 400µg groups respectively and p=0.240. The occurrence of primary postpartum haemorrhage (PPH) was equally similar between the two groups with incidence of 9.4% and 7.6% for the 200µg and 400µg groups respectively, p=0.7997. The risk ratio (RR) for developing PPH was 0.888 (95% CI; 0.537-1.467). The need for additional oxytocics to control bleeding was equally the same between the study groups with p=0.132. However, more participants in the 400µg group had one or more of the side effects of sublingual misoprostol compared to the participants in the 200µg group with RR 1.5759 (95% CI; 1.239-2.004), p<0.001. Shivering and fever were the side effects with significant difference between the two groups with p-values of 0.015 and 0.023 for shivering and fever respectively. Conclusion: Sublingual misoprostol as an adjuvant to AMTSL in the doses of 200µg and 400µg are equally effective in reducing blood loss and the incidence of primary PPH, among women at increased risk for PPH. However, misoprostol induced side effects were significantly higher with 400µg.

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