A pilot study of pre-operative misoprostol in reducing operative blood loss during hysterectomy

Eur J Obstet Gynecol Reprod Biol. 2011 Sep;158(1):72-5. doi: 10.1016/j.ejogrb.2011.03.023. Epub 2011 Apr 23.

Abstract

Objective: To investigate the effectiveness of a single pre-operative dose of sublingual misoprostol on reducing blood loss in abdominal hysterectomies performed for symptomatic uterine leiomyomas.

Study design: A cohort of 64 women undergoing total abdominal hysterectomy for symptomatic uterine leiomyomas were randomly assigned to receive a single dose of sublingual 400 mcg misoprostol (n=32) or placebo containing 20mg vitamin B(6) (n=32) 30 min before the operation. The primary outcome was the operative blood loss. The secondary outcomes were requirement for blood transfusion, change in haemoglobin level after operation, and the incidence of side effects.

Results: Women who had misoprostol were found to have similar operative blood loss to those who had placebo (570.9 ± 361.3 ml versus 521.4 ± 297.4 ml, for misoprostol and placebo group respectively; P=0.803). This study with a sample size of 64 was sufficient to have 80% power at the 5% level of significance to detect a reduction of blood loss greater than or equal to 30%. There were no observed differences in the need for post-operative blood transfusion (25% versus 15.6%, for misoprostol and placebo group respectively; P=0.536), the change in haemoglobin level after the operation, and the side effects profiles between the two groups.

Conclusion: A single pre-operative dose of sublingual misoprostol is not effective in reducing intra-operative blood loss and need for post-operative blood transfusion after total abdominal hysterectomies for symptomatic uterine leiomyomas.

Trial registration: ClinicalTrials.gov NCT01199159.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Sublingual
  • Adult
  • Blood Loss, Surgical / prevention & control*
  • Double-Blind Method
  • Female
  • Humans
  • Hysterectomy / adverse effects*
  • Leiomyoma / surgery
  • Middle Aged
  • Misoprostol / administration & dosage
  • Misoprostol / therapeutic use*
  • Oxytocics / administration & dosage
  • Oxytocics / therapeutic use*
  • Pilot Projects
  • Preoperative Care
  • Uterine Neoplasms / surgery

Substances

  • Oxytocics
  • Misoprostol

Associated data

  • ClinicalTrials.gov/NCT01199159