Misoprostol for Reduction of Blood Loss During Fibroid Surgery

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Treatments: Misoprostol; Pyridoxal; Pyridoxine; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months

• Age ≥ 18 years and ≤ 50 years

• Pre-operative hemoglobin >8 g/dl

• Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.

• Ability to understand and the willingness to sign a written informed consent.

• Admissible medical/surgical history

• Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills

• Intraoperative use of vasopressin and uterine tourniquet is permissible

• Can have had prior Cesarean delivery

Exclusion Criteria:

• Patients who have had a prior abdominal myomectomy

• Post-menopausal women

• Patients with known bleeding/clotting disorders

• Patients with a history of gynecologic malignancy

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol

• Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.