Misoprostol to lower fluid absorption during hysteroscopic myomectomy
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial
This trial will test whether a single rectal dose of misoprostol given before hysteroscopic myomectomy reduces the amount of fluid absorbed during the procedure in women with 1–3 cm uterine fibroids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07286188 on ClinicalTrials.gov |
What this trial studies
This is a double-blinded, randomized Phase 4 trial at Northwestern University comparing 800 mcg rectal misoprostol to placebo given before hysteroscopic myomectomy. Adult women aged 18–50 with 1–3 cm fibroids undergoing myomectomy with MyoSure or a resectoscope are eligible. The primary outcome is intraoperative fluid deficit volume measured during the hysteroscopy. Participants and clinicians are blinded to treatment allocation to determine whether preoperative misoprostol changes fluid absorption compared with placebo.
Who should consider this trial
Good fit: Women aged 18–50 scheduled for hysteroscopic myomectomy for 1–3 cm fibroids who can receive rectal medication and provide informed consent are the ideal candidates.
Not a fit: Postmenopausal or pregnant patients, those with fibroids outside the 1–3 cm range, people allergic to misoprostol, or those unable to have the procedure at the study site would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, a single preoperative dose of misoprostol could reduce intraoperative fluid absorption and lower the risk of fluid overload complications during hysteroscopic myomectomy.
How similar studies have performed: Misoprostol has been used off-label to aid cervical preparation and to reduce blood loss in other myomectomy settings with some positive findings, but its specific effect on fluid deficit during hysteroscopic myomectomy remains not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Northwestern — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Magy Milad, MD — Northwestern University Feinberg School of Medicine, Northwestern Department of Obstetrics and Gynecology, Division of Minimally Invasive Gyn Surgery
- Study coordinator: Hannah Pope, MD
- Email: hannah.pope@nm.org
- Phone: 3126946773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.