The Effect of Intra-myometrial Methylergonovine Injection versus Placebo on Decreasing Blood Loss during Transabdominal Myomectomy: A Randomized Controlled Interventional Clinical Trial

Abstract

Background Uterine leimyomas are tumors of the smooth muscles and the connective tissues of the uterus. They are considered to be the most common benign pelvic tumor affecting about 20% of women above the age of 35. Aim of the Work to compare the efficacy of intra-myometrial methylergonovine injection and placebo injection on reducing blood loss during trans-abdominal myomectomy. Patients and Methods The study was conducted in Ain Shams University Maternity Hospital, where 60 patients complaining of symptomatic myomas and fulfilling the inclusion criteria of the study were recruited from the gynecology outpatient clinic of the hospital. The patients were randomly categorized into two groups; Group A: the patients received 2 ampoules of methylergonovine (Novartis India Ltd) intra-myometrial, each ampule equals to 1 ml containing 0.2 mg (Methergine)® which was infiltrated sporadically into the myoma using a 5ml syringe and avoiding direct injection into vascular area and Group B: the patients received 2ml saline intra-myometrial which was infiltrated sporadically into the myoma using a 5ml syringe and avoiding direct injection into vascular area. Results the mean intraoperative blood loss in the methylergonovine group was 408 ± 70.9 ml and 573 ± 88.4 ml in the control group. There was high statistically significant difference between both groups regarding estimated intraoperative blood loss as methylergonovine injection decreased the blood loss by; 164.9±20.mL (Mean±SE). The mean post-operative haemoglobin was significantly greater in study group compared with control group (10.9±0.9 versus 10.3±1.1 g/dl) as methylergonovine injection decreased the hemoglobin drop by; 0.4±0.1 mL (Mean±SE). The mean post-operative haematocrit was significantly lower among control group compared with study group (21.4-34.2 versus 25.1-37.0 %) (P < 0.001). Methylergonovine injection decreased the hematocrit drop by; 1.4±0.1 mL (Mean±SE). In the present study, the mean difference in operative time in both groups was 8.4±2.5 minutes which had a high statistically significant difference. Conclusion Intra-operative intra-myometrial injection of 2ml methylergonovine during trans-abdominal myomectomy significantly reduces blood loss, operative time and the need for blood transfusion.