Use of Misoprostol in Hysteroscopic Myomectomy

NCT06049745 | Not Yet Recruiting Phase 4

• 1 other identifier: 0083-23-AAA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hysteroscopic myomectomy is typically suitable for myomas measuring under 4 cm in size. The utilization of misoprostol before the procedure can facilitate uterine access, decrease fluid absorption, and reduce blood loss, consequently leading to a decrease in the overall procedure time. In this randomized trial, the investigators aim to investigate the impact of misoprostol administration and its effects on each of the mentioned parameters.

Conditions

Hysteroscopic Myomectomy

Keywords

hysteroscopic myomectomy; misoprostol

Outcome Measures

Primary Outcomes (1)

• length of the procedure

  overall procedure time

  from the first insertion of the hysteroscope to the end of the procedure, minutes

Secondary Outcomes (5)

• fluid absorption

  from the start of the procedure to the end of the procedure

• success in one procedure

  from the start of the procedure to the end of the procedure

• surgical complications

  1 month folowing the procedure

• patient satisfaction

  within 30 days of the procedure

• blood loss

  from the start of the procedure until the patient has left the operating room

Study Arms (2)

hysteroscopic myomectomy without misoprostol

NO INTERVENTION

Patients undergoing hysteroscopic myomectomy that will be randomized to no intervention before the procedure.

Misoprostol group

EXPERIMENTAL

Patients undergoing hysteroscopic myomectomy will be randomized to 400 mcg of misoprostol sublingual before the procedure.

Drug: Misoprostol 400 Microgram Oral Tablet

Interventions

Misoprostol 400 Microgram Oral Tablet DRUG

S.L misoprostol 400 mcg

Misoprostol group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women between the ags of 20 years- 55 years, inclusive
• undergoing hysteroscopic myomectomy
• submucosal fibroid less than 40 mm (type 0, 1 and 2)
• up to 2 submucosal fibroids
• patients are able to provide written informed consent

You may not qualify if:

• post menopausal women
• inability to perform operative hysteroscopy under anesthesia in the past due to cervical stenosis
• previous PID or documented tubal occlusion
• positive BHCG test
• inability to consent due to cognitive or language barrier
• allergy to misoprostole
• severe COPD, asthma or cardiac disease

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead
• Assuta Medical Center: collaborator

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

Location

Related Publications (9)

• Moawad NS, Palin H. Hysteroscopic Myomectomy. Obstet Gynecol Clin North Am. 2022 Jun;49(2):329-353. doi: 10.1016/j.ogc.2022.02.012.

  PMID: 35636812 BACKGROUND

• Loddo A, Djokovic D, Drizi A, De Vree BP, Sedrati A, van Herendael BJ. Hysteroscopic myomectomy: The guidelines of the International Society for Gynecologic Endoscopy (ISGE). Eur J Obstet Gynecol Reprod Biol. 2022 Jan;268:121-128. doi: 10.1016/j.ejogrb.2021.11.434. Epub 2021 Dec 1.

  PMID: 34902749 BACKGROUND

• Zayed M, Fouda UM, Zayed SM, Elsetohy KA, Hashem AT. Hysteroscopic Myomectomy of Large Submucous Myomas in a 1-Step Procedure Using Multiple Slicing Sessions Technique. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1196-202. doi: 10.1016/j.jmig.2015.06.008. Epub 2015 Jun 18.

  PMID: 26093183 BACKGROUND

• Indraccolo U, Bini V, Favilli A. Likelihood of Accomplishing an In-Patient Hysteroscopic Myomectomy in a One-Step Procedure: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Jan 8;2020:4208497. doi: 10.1155/2020/4208497. eCollection 2020.

  PMID: 32090092 BACKGROUND

• Umranikar S, Clark TJ, Saridogan E, Miligkos D, Arambage K, Torbe E, Campo R, Di Spiezio Sardo A, Tanos V, Grimbizis G; British Society for Gynaecological Endoscopy /European Society for Gynaecological Endoscopy Guideline Development Group for Management of Fluid Distension Media in Operative Hysteroscopy. BSGE/ESGE guideline on management of fluid distension media in operative hysteroscopy. Gynecol Surg. 2016;13(4):289-303. doi: 10.1007/s10397-016-0983-z. Epub 2016 Oct 6. No abstract available.

  PMID: 28003797 BACKGROUND

• Murakami T, Shimizu T, Katahira A, Terada Y, Yokomizo R, Sawada R. Intraoperative injection of prostaglandin F2alpha in a patient undergoing hysteroscopic myomectomy. Fertil Steril. 2003 Jun;79(6):1439-41. doi: 10.1016/s0015-0282(03)00386-8.

  PMID: 12798895 BACKGROUND

• Indman PD. Use of carboprost to facilitate hysteroscopic resection of submucous myomas. J Am Assoc Gynecol Laparosc. 2004 Feb;11(1):68-72. doi: 10.1016/s1074-3804(05)60014-x.

  PMID: 15104835 BACKGROUND

• Al-Fozan H, Firwana B, Al Kadri H, Hassan S, Tulandi T. Preoperative ripening of the cervix before operative hysteroscopy. Cochrane Database Syst Rev. 2015 Apr 23;2015(4):CD005998. doi: 10.1002/14651858.CD005998.pub2.

  PMID: 25906113 BACKGROUND

• Lasmar RB, Lasmar BP, Celeste RK, da Rosa DB, Depes Dde B, Lopes RG. A new system to classify submucous myomas: a Brazilian multicenter study. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):575-80. doi: 10.1016/j.jmig.2012.03.026. Epub 2012 Jul 20.

  PMID: 22819007 BACKGROUND

Central Study Contacts

oshri barel

CONTACT

972 55 938 2117; oshrib@assuta.co.il

alona doron lalehzari

CONTACT

972 50 880 7991; alonado@assuta.co.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gynecology Division, Department of Obstetrics and Gynecology. Assuta Ashdod University Hospital

Model Details: patients undergoing hysteroscopic myomectomy will be divided into two groups, the study group will receive misoprostol before the procedure. the control group will not receive treatment with misoprostol.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 22, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)