Status:
TERMINATED
Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Lead Sponsor:
Northwestern University
Conditions:
Fibroids
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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) m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02209545
Start Date
October 1 2014
End Date
July 1 2022
Last Update
September 7 2023
Active Locations (1)
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1
Northwestern University, Prentice Women's Hospital
Chicago, Illinois, United States, 60611