Abstract
Introductionsingle-dose of sublingual misoprostol 400mcg with the participant followed-up at the gynecology clinic one week after with an ultrasound scan for the completeness of the uterine evacuation. Objective: to compare the effectiveness of single-dose sublingual misoprostol to manual vacuum aspiration in the treatment of incomplete spontaneous abortion in Enugu, Nigeria.Methodsthe primary outcome measure was the incidence of complete uterine evacuation (complete abortion) after one week of treatment while the secondary outcome measures included incidence, types, and tolerability of treatment side effects as well as participants' satisfaction with the treatment received.Resultstwo hundred and three participants who met the study criteria and completed the study were randomised into the intervention group (n=102) received single-dose sublingual misoprostol 400mcg and the control group (n= 101) received manual vacuum aspiration. Incidence of complete abortion was 86.3% for the misoprostol group and 100.0% for the control group, RR = 0.86, (CI 95%: 0.80 - 0.93), p <0.001. The most common side effect was abdominal pain with an incidence of 27.5% versus 48.55 for the misoprostol and control groups respectively (p = 0.002). Most participants in each group (81.1% versus 77.6% for the misoprostol and control groups respectively) considered the side effects as tolerable. The mean visual analogue scale score for maternal satisfaction was higher in the misoprostol group (86.7 ± 14.11) than the control group (81.36 ± 11.10), p < 0.001.Conclusionthe treatment of incomplete spontaneous abortion with single-dose sublingual misoprostol 400mcg produced a high rate of complete abortion among women in Enugu, Nigeria. Despite having a lower complete abortion rate, maternal satisfaction was higher when compared with women that had manual vacuum aspiration of the uterus. Trial registration: trial registration number - PACTR202009857889210, date of registration - September 23rd, 2020. Retrospectively registered.
Highlights
Abortion which can be spontaneous or induced contributes up to 13.2% of all maternal deaths globally. [1] It is referred to as incomplete when the products of conception are retained within the uterine cavity and may lead to complications such as hemorrhage, infection, renal failure, and death
The treatment of incomplete spontaneous abortion with single-dose sublingual misoprostol 400mcg produced a high rate of complete abortion among women in Enugu, Nigeria
Despite having a lower complete abortion rate, maternal satisfaction was higher when compared with women that had manual vacuum aspiration of the uterus
Summary
Abortion which can be spontaneous or induced contributes up to 13.2% of all maternal deaths globally. [1] It is referred to as incomplete when the products of conception are retained within the uterine cavity and may lead to complications such as hemorrhage, infection, renal failure, and death. Though MVA is a safe and effective treatment option for early pregnancy loss,[5] its accessibility in low resource countries is constrained by the unavailability of sterile equipment and skilled provider generally,[6] as well as other challenges such as the need for theatre space, cost of the procedure, and peculiar complications including cervical trauma and uterine perforation. Because of these constraints, there was a need to explore effective, accessible, & acceptable non-surgical options
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