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 |
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.
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.
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
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