RecruitingPhase 4NCT07286188

Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy

Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial


Sponsor

Northwestern University

Enrollment

40 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria9

  • 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

Exclusion Criteria6

  • 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.

Interventions

DRUGMisoprostol Tabets

800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.

DRUGPlacebo

4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.


Locations(1)

Northwestern

Chicago, Illinois, United States

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NCT07286188