NCT07286188 Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
| NCT ID | NCT07286188 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwestern University |
| Condition | Fibroids, Uterine |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2025-12-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Magy Milad, MD
PRINCIPAL INVESTIGATOR
Northwestern University Feinberg School of Medicine, Northwestern Department of Obstetrics and Gynecology, Division of Minimally Invasive Gyn Surgery
Frequently Asked Questions
Who can join the NCT07286188 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Fibroids, Uterine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07286188 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07286188 currently recruiting?
Yes, NCT07286188 is actively recruiting participants. Contact the research team at hannah.pope@nm.org for enrollment information.
Where is the NCT07286188 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07286188 clinical trial?
NCT07286188 is sponsored by Northwestern University. The principal investigator is Magy Milad, MD at Northwestern University Feinberg School of Medicine, Northwestern Department of Obstetrics and Gynecology, Division of Minimally Invasive Gyn Surgery. The trial plans to enroll 40 participants.