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Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Primary Purpose

Fibroids

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Misoprostol

Placebo

About this trial

This is an interventional treatment trial for Fibroids focused on measuring fibroids, leiomyomata, blood loss, misoprostol

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Northwestern University, Prentice Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Misoprostol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Procedure

Intra-operative time

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.

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).

Full Information

NCT ID

NCT02209545

First Posted

July 23, 2014

Last Updated

August 12, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT02209545

Brief Title

Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

The study was prematurely closed due to low enrollment rates.

Study Start Date

October 2014 (undefined)

Primary Completion Date

July 2022 (Actual)

Study Completion Date

July 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibroids

Keywords

fibroids, leiomyomata, blood loss, misoprostol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Misoprostol

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Cytotec

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Vitamin B6 (pyridoxine)

Intervention Description

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

Primary Outcome Measure Information:

Title

Estimated Intra-operative Blood Loss

Description

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.

Time Frame

Intra-operative

Secondary Outcome Measure Information:

Title

Duration of Procedure

Description

Intra-operative time

Time Frame

Intra-operative

Title

Length of Inpatient Hospitalization

Description

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.

Time Frame

Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively

Title

Post-operative Blood Transfusion

Description

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).

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magdy Milad, MD

Organizational Affiliation

Northwestern University, Northwestern Memorial Hopsital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University, Prentice Women's Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Misoprostol for Reduction of Blood Loss During Fibroid Surgery

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