Outcomes of Medical versus Surgical Management of Incomplete Abortion in Uganda. an Open Labeled Randomized Clinical Trial

Abstract

Background: Management decision on whether to use medical or surgical method in women diagnosed with incomplete abortion particularly in the first trimester has been a controversial topic in Uganda and the world in general with no local studies comparing effectiveness and secondary outcomes between the two approaches. This has posed a big challenge to the attending clinicians as regards making informed management options when encountered with such cases.Methods: A five months prospective open labeled randomized clinical trial involving 100 consecutively recruited participants was conducted from June 1st, 2018 to October 30th, 2018. Ethical clearance was obtained from KIUREC and UNCST. Data collection was achieved using an investigator administered questionnaire; in-depth face to face interviews as well as laboratory and ultrasound scan report forms. Baseline demographic and clinical characteristics were assessed using univariate analysis. Statistical difference was considered when p<0.05. Numerical variables were summarized using means, medians for non-normally distributed variables, and frequencies or proportions for categorical variables. All statistical analysis was carried out using IBM SPSS Statistics software version 23.0. Results: The effectiveness of surgical management was higher than that of medical management (RRR=11.7%; p=0.043). Majority in the medical arm reported mild pain (64% vs 4%; p<0.001) while most of those in surgical arm reported severe pain (78% vs 8%; p<0.001). Bleeding was prolonged in the medical arm method with majority of those in surgical arm reporting bleeding for less than six hours (94% vs 46%; p=0.0002). Although medical method had longer bleeding, it was associated with lesser symptoms of headache, dizziness, syncope and blood transfusion. 90% of those in medical arm and only 50% of those in surgical method would recommend the method assigned (p<0.001). Fever, chills and nausea were more common in medical method. Average hospital stay was longer in medical method (p=0.03). Only one participant in surgical arm developed infection while no patient had genitourinary trauma. There was no statistical significant difference between the satisfaction levels in the two arms. Conclusion: Surgical management is more effective than medical management. Although medical management has prolonged expulsion bleeding, prolonged hospital stay and increased fevers, chills and nausea that are self-limiting; it has reduced pain. Most patients are satisfied with and would recommend medical management.