Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.

NCT06882824 | Recruiting

• 1 other identifier: RBHP 2024 GREMEAU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In France, uterine fibroids or leiomyomas are the most common benign tumour in women of childbearing age. In 30% of cases, fibroids are symptomatic (menorrhagia, anaemia, pain), in which case surgical management is indicated. This is known as myomectomy, and can be performed by hysteroscopy, laparoscopy (laparoscopy) or laparotomy, depending on the number, size and position of the fibroids. Intraoperative bleeding is the main surgical difficulty. For this reason, a number of studies have focused on ways of minimizing the risk of bleeding. A good surgical indication, prevention of anaemia (iron deficiency) and transient occlusion of the uterine arteries during surgery help to reduce this risk. There are also drugs available to reduce intraoperative bleeding, but few studies have been carried out to assess their real effectiveness. One such product is Misoprostol, commonly used in gynecology. Its muscle-contracting properties suggest that it could have a beneficial effect on bleeding during surgery. What's more, this treatment has been used for many years and is reputed to be very well tolerated. The most frequent side effects are digestive, with a risk of abdominal pain in the form of cramps, nausea or vomiting. The investigators therefore decided to set up the HEMOMYOC study to demonstrate a significant reduction in bleeding during laparotomy or laparoscopic myomectomy after taking oral misoprostol in combination with transient occlusion of the uterine arteries, compared with placebo. It would seem that the ease of use and good tolerance of misoprostol, in combination with transient occlusion of the uterine arteries, could be of real benefit in preventing intraoperative morbidity in myomectomies, whatever the surgical approach. To date, no studies have been carried out in this area.

Conditions

Myoma;Uterus; Myomectomy; Surgical Blood Loss

Keywords

myomectomy; surgical blood loss; misoprostol

Outcome Measures

Primary Outcomes (1)

• Evaluation of intraoperative blood loss (in milliliters) during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of type of surgery.

  during surgery

Secondary Outcomes (29)

• Evaluate intraoperative blood loss (in milliliters) during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) according to surgical technique, laparoscopy and laparotomy.

  during surgery

• Compare Hemoglobin level (in g/L) between experimental and control groups

  between day before surgery and day of surgery

• Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery

  between day before surgery and day of surgery

• Compare between experimental and control groups: Patient age

  at inclusion

• Compare between laparotomy and laparoscopy: Patient age

  at inclusion

Study Arms (2)

treatment arm with misoprostol

EXPERIMENTAL

Procedure: myomectomy with misoprostol

Placebo arm

PLACEBO COMPARATOR

Procedure: myomectomy with placebo

Interventions

myomectomy with placebo PROCEDURE

myomectomy after administration of placebo (control group)

Placebo arm

myomectomy with misoprostol PROCEDURE

myomectomiy after administration of misoprostol 400μg PO (experimental group)

treatment arm with misoprostol

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged 18 to 43
• Symptomatic myomas (bleeding, pain or infertility)
• Indication for laparoscopic myomectomy Fibroma ≤ 10cm or number ≤ to 4 fibroids
• Indication for myomectomy by laparotomy Fibroma \> 10cm, Number \> to 4 fibroids
• OTAU possible intraoperatively (Clip on uterine artery and tourniquet placement)
• Speak and understand French
• Affiliated with a social security scheme.

You may not qualify if:

• History of major uterine surgery or myomectomy (excluding hysteroscopic myomectomy)
• Allergy to misoprostol and lactose
• Patients with hypersensitivity to misoprostol and/or other prostaglandins or to any of the product's excipients.
• Patients taking aspirin or anti-coagulants
• Patients with haemostasis disorders
• Malnourished patients
• Patients with hepatic or renal insufficiency
• Pregnancy, suspected ectopic pregnancy and breast-feeding women.
• Minors
• Guardianship, curatorship, deprived of liberty, safeguard of justice

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Myofibroma; Blood Loss, Surgical

Interventions

Uterine Myomectomy; Misoprostol

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Anne-Sophie GREMEAU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_internet_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: March 19, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): April 17, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-03

Locations

FR (1)