Randomised Controlled Trial: Intrauterine Misoprostol Versus Sublingual Misoprostol In The Prevention Of Postpartum Hemorrhage At Elective Caesarean Section At Korle Bu Teaching Hospital, Ghana. - Trial PACTR202309644870215

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Summary

Postpartum haemorrhage is a major global problem and remains a leading cause of maternal mortality in Ghana, and other sub-Saharan African countries. According to WHO, obstetric haemorrhage (antepartum and postpartum haemorrhage) accounts for more than a quarter of maternal deaths (330,000 maternal deaths) in 2015. Misoprostol is one of the drugs on the WHO model list of essential medicines and is commonly used in LMICs in the prevention of primary postpartum haemorrhage. Different routes have been recommended by the WHO for the administration of Misoprostol, however, most routes have been fraught with unwanted side effects.The aim of the trial is to determine the effectiveness of intrauterine misoprostol compared to sublingual misoprostol in the prevention of postpartum haemorrhage among women undergoing elective Caesarean section in Korle-Bu Teaching hospital. OBJECTIVES:1. To compare the blood loss after delivery of placenta to 3 hours post-delivery (overall blood loss) between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin.2. To compare the pre-operative and 24-hour post-operative haematocrit levels between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin. 3. To compare the need for additional PPH interventions (additional uterotonics, blood transfusion, uterine tamponade, compression sutures, artery ligation, hysterectomy, relaparotomy and admission to ICU) applied in the first 24 hours following delivery between women who received 400mcg intrauterine misoprostol plus 5IU IV oxytocin and those who received 600mcg sublingual misoprostol plus 5IU IV oxytocin4. To compare the side effects profile of 400mcg intrauterine misoprostol plus 5IU IV oxytocin with that of 600mcg sublingual misoprostol plus 5IU IV oxytocin in the first 3 hours following administration.

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