Clinical trial · Interventional
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy
Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy: A Double-Blinded Randomized Controlled Trial
NCT07286188CI-TRIAL-00113157recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroids, Uterine | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Fluid Deficit | — | UNRESOLVED | — |
| Hysteroscopy / Methods | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Misoprostol Tabets | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Misoprostol (treatment aem)
- description
- Patients will received 800 mcg of misoprostol per rectum prior to procedure.
- interventionNames
- Drug: Misoprostol Tabets
- type
- PLACEBO_COMPARATOR
- label
- Zeebo (Placebo arm)
- description
- Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Fluid Deficit
- timeFrame
- Immediately at the conclusion of the procedure.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDInacio QAS, Troncon JK, Valerio FP, Herren H, Nogueira AA, Neto OBP, Silva JCRE. Misoprostol Administration Before Hysteroscopy Procedures - A Retrospective Analysis. Rev Bras Ginecol Obstet. 2022 Dec;44(12):1102-1109. doi: 10.1055/s-0042-1755462. Epub 2022 Aug 29. PMID 36037813
- BACKGROUNDGuven CM, Avul Z. Evaluation of the effect of preoperative rectal misoprostol use on the postoperative outcomes of hysteroscopic myomectomy. J Obstet Gynaecol Res. 2023 Aug;49(8):2086-2092. doi: 10.1111/jog.15681. Epub 2023 May 19. PMID 37208944
- BACKGROUNDDesilets J, Zakhari A, Chagnon M, Ekmekjian T, Nguyen DB, Smith JP, Mansour FW, Krishnamurthy S. Pharmacologic Interventions to Minimize Fluid Absorption at the Time of Hysteroscopy: A Systematic Review and Meta-analysis. Obstet Gynecol. 2023 Feb 1;141(2):285-298. doi: 10.1097/AOG.0000000000005051. Epub 2023 Jan 4. PMID 36649319
- BACKGROUNDWelch K, Ek R, Stromme M. Comparative drug release measurements in limited amounts of liquid: a suppository formulation study. Curr Drug Deliv. 2006 Jul;3(3):299-306. doi: 10.2174/156720106777731109. PMID 16848731
- BACKGROUNDBianchi M, Capurso L. Effects of guar gum, ispaghula and microcrystalline cellulose on abdominal symptoms, gastric emptying, orocaecal transit time and gas production in healthy volunteers. Dig Liver Dis. 2002 Sep;34 Suppl 2:S129-33. doi: 10.1016/s1590-8658(02)80180-3. PMID 12408456
- BACKGROUNDVilos GA, Vilos AG, Abu-Rafea B, Ternamian A, Laberge P, Munro MG. Good practice with fluid management in operative hysteroscopy. Int J Gynaecol Obstet. 2025 Jan;168(1):118-125. doi: 10.1002/ijgo.15860. Epub 2024 Aug 22. PMID 39171580