Misoprostol for Reduction of Blood Loss During Fibroid Surgery
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Fibroids
In brief
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.
Key facts
- Study ID
- NCT02209545
- Run by
- Northwestern University
- People needed
- 47
- Starts
- 2014-10-01
- Expected to finish
- 2022-07-01
- Last updated by the study team
- 2023-09-07
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Northwestern University, Prentice Women's Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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