Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Fibroids, Uterine, Fluid Deficit, Hysteroscopy / Methods
In brief
The goal of this double blinded randomized control trial is to evaluate the impact of misoprostol on fluid deficit during hysteroscopic myomectomies. The main questions it aims to answer are: Is there is difference in fluid deficit in patients who receive misoprostol vs placebo pre operatively for hysteroscopic myomectomies? Participants will be randomized to received 800 mcg of either rectal misoprostol prior to their hysteroscopic myomectomy or 4 tablets of placebo (ZEEBO) prior to their hysteroscopic myomectomy.
Key facts
- Study ID
- NCT07286188
- Run by
- Northwestern University
- People needed
- 40
- Starts
- 2025-12-16
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients presenting for hysteroscopic myomectomy for uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
- Age ≥ 18 years and ≤ 50 years.
- Fibroids between 1-3cm in size
- Myomectomy using myosure or resectoscope devices
- Willing to have rectal misoprostol or placebo at time of 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
- Can have had prior Cesarean delivery
You may not qualify if…
- Pregnancy. All patients will be required to have a negative urine pregnancy test prior to surgery.
- Post-menopausal women.
- Patients with a history of gynecologic malignancy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol.
- 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.
- Known active inflammatory bowel disease involving the rectum or other significant anorectal conditions that may interfere with safe rectal administration of study medication.
Where it is running
- Northwestern — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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