Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fibroids

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibroids, leiomyomata, blood loss, misoprostol