Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Northwestern University

Status and phase: Terminated; Phase 4

Conditions: Fibroids

Treatments: Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02209545

STU00091259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo