Misoprostol for Reduction of Blood Loss During Fibroid Surgery

NCT02209545 | Terminated Phase 4 Results

• 1 other identifier: STU00091259
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroids

Keywords

fibroids, leiomyomata, blood loss, misoprostol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration of Procedure

  Intra-operative

• Length of Inpatient Hospitalization

  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

  From time of surgery completion through discharge from hospital, an expected average period of 3 days

Study Arms (2)

Misoprostol

EXPERIMENTAL

25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.

Drug: Placebo

Interventions

Misoprostol DRUG

25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.

Also known as: Cytotec

Misoprostol

Placebo DRUG

25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.

Also known as: Vitamin B6 (pyridoxine)

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Leiomyoma; Hemorrhage

Interventions

Misoprostol; Vitamin B 6

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Magdy Milad
• Organization: Northwestern Medicine

mmilad@nm.org

3126946447

Study Officials

• Magdy Milad, MD

  Northwestern University, Northwestern Memorial Hopsital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Obstetrics and Gynecology, Reproductive Endo & Infertility

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: August 6, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)