Efficacy and Safety of Pre-operative Vaginal Misoprostol in Reduction of Intraoperative Blood Loss During Myomectomy. Amulticentre Single Blind Randomized Trial.

Uterine fibroids are the commonest benign gynecological tumors in pre-menopausal women affecting over 80% of African women by age of 50. Myomas are clinically apparent in approximately 12 to 25% of reproductive age women and noted coincidentally on pathological examination in approximately 80% of surgically excised uteri. Fibroids; clinically apparent in up to one third of women in reproductive age, cause significant morbidity including prolonged or heavy menstrual bleeding, pelvic pressure or pain, dyspareunia and in other cases, reproductive dysfunction; all of which affect their quality of life. Although, the definitive mode of management is complete uterine removal (Hysterectomy), a significant fraction of patients prefer preserving their uterus irrespective of fertility desires. Myomectomy remains the mainstay of management for such patients. Open myomectomy, is a major surgical procedure associated with considerable morbidity with significant intraoperative hemorrhage. Fletcher in 1996 reported that 23% patients undergoing open myomectomy lost over 1000ml of blood. Another study of 91 women who underwent this procedure for uterine size greater than 16 weeks, the operative blood loss ranged between 50ml and 3000 ml. Other series reported transfusion rates between 18% and 24%. Surgical hemorrhage may result in anemia, hypovolemia, and coagulation abnormalities.

Despite the many advances in therapeutic options for uterine masses, open myomectomy poses the most efficacious mode of management in resource limited settings for symptomatic relief in women that wish to preserve their uteri. Laparoscopic myomectomy would offer a relatively more cosmetic and blood-sparing alternative but the high costs and the need for proficient personnel have left its advent in developing countries elusive.

Numerous strategies to reduce blood loss during abdominal myomectomy both mechanical and pharmacologic techniques have been tried but excessive hemorrhage during abdominal myomectomy remains a challenge to gynecologic surgeons.

Pre-operative prostaglandins, have offered a more reliable and realistic hope in resource-limited settings to lower intraoperative blood loss. It stimulates uterine contractions and this leads to occlusion of the vessels supplying blood to the leiomyomas. These strong myometrial contractions induced by misoprostol indirectly cause relative avascularity in the myoma and contributes to a reduction in bleeding. This subsequently may redistribute the blood from the diseased uterus back to the circulation, hence reducing operative blood loss during abdominal myomectomy. A few studies done have demonstrated safety and efficacy.

The complications and burden of this hemorrhage are even greater in resource-limited settings. In Mulago National Referral Hospital, Misoprostol has not been assimilated into the standard of care for reduction of intraoperative blood loss during open myomectomy. This study aims to assess the efficacy and safety of Misoprostol in such settings.