Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Key facts
- Who runs it
- Northwestern University
- Where
- Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 40 people, planned
- Started
- 16 Dec 2025
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Misoprostol Tabets
- Placebo
- Record updated
- 1 June 2026
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Pregnancy. All patients will be required to have a negative urine pregnancy test prior to surgery
- 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
- Post-menopausal women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- NorthwesternChicago, United StatesContact: Hannah Pope, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 2 groups in the trial
- Misoprostol (treatment aem)Treatment being tested
Patients will received 800 mcg of misoprostol per rectum prior to procedure.
Treatment: Misoprostol Tabets
- Zeebo (Placebo arm)Placebo, for comparison
Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial
- Fit questions
- Built from NCT07286188, who can take part
- Record updated
- 1 June 2026