Can a simple pill make fibroid surgery safer?
NCT ID NCT07286188
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving misoprostol (a drug often used for stomach ulcers and labor) before hysteroscopic fibroid removal can reduce the amount of fluid absorbed by the body during surgery. Too much fluid can be dangerous. Forty women with small fibroids (1-3 cm) will receive either misoprostol or a placebo rectally before their procedure. The main goal is to see if misoprostol lowers fluid deficit, with secondary looks at surgery time and need for repeat procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- misoprostol
- What this could lead to
- If it works, this could help reduce the risk of fluid overload during hysteroscopic fibroid surgery, making the procedure safer.
- What could go wrong
- This is a small, early-phase trial with only 40 participants, so results may not apply widely. Misoprostol may not reduce fluid deficit or could cause side effects like cramping or nausea.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern
RECRUITINGChicago, Illinois, 60611, United States
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