Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-07-31

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.

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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.

Conditions

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Fibroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Misoprostol

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

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Misoprostol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cytotec Vitamin B6 (pyridoxine)

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes