Effect of Misoprostol on Fluid Deficit Volume in Hysteroscopic Myomectomy

NCT07286188 | Recruiting Phase 4 FDA Drug

• 1 other identifier: #STU00223642
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibroids, Uterine; Fluid Deficit; Hysteroscopy / Methods

Keywords

fibroids; hysteroscopy; myomectomy; fluid deficit; misoprostol

Outcome Measures

Primary Outcomes (1)

• Fluid Deficit

  Primary outcome is difference in fluid deficit at the conclusion of the hysteroscopic myomectomy

  Immediately at the conclusion of the procedure.

Secondary Outcomes (4)

• Total fluid volume

  intraoperative

• Time

  Intraop

• Reoperation

  within 3 month post op

• Specimen weight

  Immediately post op

Study Arms (2)

Misoprostol (treatment aem)

EXPERIMENTAL

Patients will received 800 mcg of misoprostol per rectum prior to procedure.

Drug: Misoprostol Tabets

Zeebo (Placebo arm)

PLACEBO COMPARATOR

Patient will receive 4 tablets of placebo (ZEEBO) per rectum prior to procedure.

Drug: Placebo

Interventions

Misoprostol Tabets DRUG

800 mcg of misoprostol will be administered per rectum to intervention group prior to their scheduled hysteroscopic myomectomy.

Misoprostol (treatment aem)

Placebo DRUG

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.

Zeebo (Placebo arm)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (6)

• Inacio 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 BACKGROUND

• Guven 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 BACKGROUND

• Desilets 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 BACKGROUND

• Welch 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 BACKGROUND

• Bianchi 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 BACKGROUND

• Vilos 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 BACKGROUND

Related Links

• Safety of Misoprostol
• Microcrystalline Cellulose

MeSH Terms

Conditions

Leiomyoma; Hypovolemia

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magy Milad, MD

  Northwestern University Feinberg School of Medicine, Northwestern Department of Obstetrics and Gynecology, Division of Minimally Invasive Gyn Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Pope, MD

CONTACT

3126946773; hannah.pope@nm.org

Juan Avitia, MPH

CONTACT

juan.avitia1@nm.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient, surgeon, and research team are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Albert B Gerbie Professor

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)