Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02209545

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroids	Drug: Misoprostol Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Estimated intra-operative blood loss [Intra-operative]
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]
Intra-operative time
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]
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 [From time of surgery completion through discharge from hospital, an expected average period of 3 days]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.