Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Buccal Misoprostol Prior to Abdominal Myomectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Fibroids
• Intervention / Treatment: Drug: Misoprostol; Drug: Placebo

Detailed Description

This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Prentice Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Misoprostol; 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.	Drug: Misoprostol; 25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.; Other Names: Cytotec
Placebo Comparator: Placebo; 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.	Drug: Placebo; 25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.; Other Names: Vitamin B6 (pyridoxine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Intra-operative Blood Loss	Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.	Intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Procedure	Intra-operative time	Intra-operative
Length of Inpatient Hospitalization	Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.	Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively
Post-operative Blood Transfusion	Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).	From time of surgery completion through discharge from hospital, an expected average period of 3 days

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Magdy Milad, MD, Northwestern University, Northwestern Memorial Hopsital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimated): August 6, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: fibroids, leiomyomata, blood loss, misoprostol
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Hemorrhage; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Gastrointestinal Agents; Micronutrients; Vitamins; Reproductive Control Agents; Anti-Ulcer Agents; Vitamin B Complex; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Vitamin B 6; Pyridoxine
• Other Study ID Numbers: STU00091259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO