Preoperative Sublingual Misoprostol for Intraoperative Blood Loss Reduction in Total Abdominal Hysterectomy: A Randomized Controlled Trial.

Background and objective Total abdominal hysterectomy represents one of the most frequently performed gynecological procedures globally, with intraoperative hemorrhage constituting a significant clinical concern impacting surgical outcomes and patient morbidity. Misoprostol, a synthetic prostaglandin E1 analog, demonstrates established uterotonic properties with potential hemostatic benefits in gynecological surgery. This randomized controlled trial aimed to evaluate the efficacy of a preoperative single sublingual dose of 400 μg misoprostol versus placebo in reducing mean operative blood loss during total abdominal hysterectomy among women undergoing elective procedures. Methodology This randomized controlled trial (Trial registration number: SPH0000567) was conducted at the Department of Obstetrics and Gynecology Unit-I, Sandeman Provincial Hospital, Quetta, from October 2015 to April 2016. The study enrolled 434 women aged 18-70 years undergoing elective total abdominal hysterectomy, randomly allocated into two groups using computer-generated randomization with sealed envelope concealment. Group A received a single sublingual folic acid tablet of 5 mg 30 minutes preoperatively, while Group B received a single sublingual misoprostol tablet of 400 μg 30 minutes before surgery. The primary outcome measure was mean operative blood loss, calculated through a comprehensive methodology incorporating suction chamber volume and gravimetric gauze weight measurement. Secondary endpoints included operative duration, postoperative hemoglobin drop, transfusion requirements, and adverse event profile. All surgical procedures were performed by a single surgical team, with blood loss measurement conducted by a single resident to eliminate inter-observer bias. Double-blinding was maintained, and outcome assessors were masked to treatment allocation. Results The study demonstrated a statistically significant reduction in mean operative blood loss in the misoprostol group compared to the placebo group, with values of 364.55±53.26 ml versus 422.65±56.77 ml, respectively, representing a mean difference of 58.1 ml (13.7%) reduction (p<0.001). Age-stratified analysis revealed consistent hemostatic efficacy across all demographic categories: 35-40 years group 361.97±56.25 ml versus 420.11±51.95 ml (p<0.001), 41-45 years group 367.43±43.05 ml versus 419.07±62.96 ml (p<0.001), and 46-50 years group 362.79±60.96 ml versus 426.67±53.26 ml (p<0.001). Parity-based subgroup analysis demonstrated universal statistical significance across nulliparous, primiparous, multiparous, and grand multiparous women. Secondary endpoints revealed significant reductions in postoperative hemoglobin drop, 1.85±0.42 g/dl versus 2.34±0.56 g/dl (p<0.001), and transfusion requirements, 8 patients (3.7%) versus 23 patients (10.6%) (p=0.003), representing a 65% relative risk reduction. Hospital length of stay was reduced to 2.8±0.6 days versus 3.1±0.7 days (p=0.012). Adverse events were predominantly gastrointestinal, with a higher incidence in the misoprostol group, but no serious complications were reported. Conclusion Preoperative sublingual misoprostol 400 μg administered 30 minutes before total abdominal hysterectomy significantly reduces intraoperative blood loss with an acceptable safety profile. The intervention demonstrates universal efficacy across age and parity subgroups, supporting routine clinical implementation for hemorrhage prevention in gynecological surgery.