Misoprostol for Reduction of Blood Loss During Fibroid Surgery



Status:Recruiting
Healthy:No
Age Range:18 - 50
Updated:7/14/2018
Start Date:October 2014
End Date:May 2020
Contact:Magdy Milad, MD
Email:mmilad@nm.org
Phone:312-472-4673

Use our guide to learn which trials are right for you!

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

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.

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.

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.
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Magdy Milad, MD
?
mi
from
Chicago, IL
Click here to add this to my saved trials