Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNorthwestern University
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Misoprostol Tabets
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov