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De klinische studie NCT07286188 voor Fibroids, Uterine, Fluid Deficit, Hysteroscopy / Methods is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy Fase 4 40 Gerandomiseerd Dubbelblind

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De klinische studie NCT07286188 onderzoekt behandeling bij Fibroids, Uterine, Fluid Deficit, Hysteroscopy / Methods. Deze Fase 4 interventioneel-studie heeft de status rekruterend. Het doel is om 40 deelnemers te includeren vanaf 16 december 2025. De studie wordt geleid door Northwestern-universiteit en de voltooiing is gepland op 1 december 2026. Laatste update op ClinicalTrials.gov: 17 december 2025.
Beknopte samenvatting
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 t...

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Uitgebreide beschrijving
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 hemorrhag...Toon meer
Officiële titel

Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial

Aandoeningen
Fibroids, UterineFluid DeficitHysteroscopy / Methods
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • #STU00223642
NCT-ID
NCT07286188
Startdatum (Werkelijk)
2025-12-16
Laatste update geplaatst
2025-12-17
Verwachte einddatum
2026-12
Inschrijving (Geschat)
40
Studietype
Interventioneel
FASE
Fase 4
Status
Rekruterend
Trefwoorden
fibroids
hysteroscopy
myomectomy
fluid deficit
misoprostol
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelMisoprostol (treatment aem)
Patients will received 800 mcg of misoprostol per rectum prior to procedure.
Misoprostol Tabets
800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.
Placebo-comparatorZeebo (Placebo arm)
Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.
PLACEBO
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.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Fluid Deficit
Primary outcome is difference in fluid deficit at the conclusion of the hysteroscopic myomectomy
Immediately at the conclusion of the procedure.
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Total fluid volume
Difference in total fluid volume used (in milliliters) between groups.
intraoperative
Time
Difference in total procedure time (in minutes) between groups.
Intraop
Reoperation
Frequency of repeat hysteroscopic myomectomy due to incomplete fibroid resection caused by early termination of the initial procedure
within 3 month post op
Specimen weight
Total specimen weight
Immediately post op
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
  • 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

  • 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.
Northwestern University logoNorthwestern-universiteit
Verantwoordelijke instantie
Magdy Milad, MD, Hoofdonderzoeker, Albert B Gerbie Professor, Northwestern University
Centraal Contactpersoon
Contact: Hannah Pope, MD, 3126946773, [email protected]
Contact: Juan Avitia, [email protected]
1 Studielocaties in 1 landen

Illinois

Northwestern, Chicago, Illinois, 60611, United States
Hannah Pope, MD, Contact, 312-694-6773, [email protected]
Juan Avitia, Contact, [email protected]
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