Misoprostol to lower fluid absorption during hysteroscopic myomectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.