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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern
RECRUITING
Chicago
Contact Information
Primary
Hannah Pope, MD
hannah.pope@nm.org
3126946773
Backup
Juan Avitia
juan.avitia1@nm.org
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: Misoprostol (treatment aem)
Patients will received 800 mcg of misoprostol per rectum prior to procedure.
Placebo_comparator: Zeebo (Placebo arm)
Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University

This content was sourced from clinicaltrials.gov