Clinical trial NCT02209545: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fibroids
Keywords: fibroids, leiomyomata, blood loss, misoprostol
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Estimated Intra-operative Blood Loss
timeFrame: Intra-operative
Secondary outcomes:
measure: Duration of Procedure
timeFrame: Intra-operative
measure: Length of Inpatient Hospitalization
timeFrame: Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively
measure: Post-operative Blood Transfusion
timeFrame: From time of surgery completion through discharge from hospital, an expected average period of 3 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University, Northwestern Memorial Hopsital
name: Magdy Milad, MD
role: PRINCIPAL_INVESTIGATOR
References: