Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02209545
• Other study ID #: STU00091259
• Status: Terminated
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: July 2022

Study information

• Verified date: August 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibroids
• Hemorrhage
• Leiomyoma

Intervention

Drug:
• Misoprostol
25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
• Placebo
25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.

Locations

Country	Name	City	State
United States	Northwestern University, Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Procedure	Intra-operative time	Intra-operative
Secondary	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
Secondary	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