Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial
Northwestern University
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.
Description
Misoprostol is a synthetic analogue of prostaglandin E1 originally developed for the prevention and treatment of NSAID-induced peptic ulcers. Over time, it has become widely used in obstetrics and gynecology due to its uterotonic properties. It is FDA-approved as part of the regimen, paired with mifepristone, for medical abortion and is commonly used off-label for cervical ripening, management of postpartum hemorrhage, and preoperative preparation for gynecologic procedures. In non-pregnant women, misoprostol is frequently administered prior to procedures such as hysteroscopy, intrauterine dev…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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 Excl…
Interventions
- DrugMisoprostol Tabets
800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.
- DrugPlacebo
4 tablets of Zeebo (Microcsrystalline cellulose) placebo tablets will be placed per rectum to prior to undergoing a hysteroscopic myomectomy, for patients assigned to the placebo arm.
Location
- NorthwesternChicago, Illinois