Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol. (HEMOMYOC)

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.

Study Overview

• Status: Recruiting
• Conditions: Myoma;Uterus; Myomectomy; Surgical Blood Loss
• Intervention / Treatment: Procedure: myomectomy with misoprostol; Procedure: myomectomy with placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise LACLAUTRE; Phone Number: +33473754963; Email: promo_internet_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand
    • Clermont-Ferrand, Clermont-Ferrand, France, 63000
      • Recruiting
      • Chu Clermont-Ferrand
      • Principal Investigator: Anne-Sophie GREMEAU
      • Contact: Lise LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm	Procedure: myomectomy with placebo; myomectomy after administration of placebo (control group)
Experimental: treatment arm with misoprostol	Procedure: myomectomy with misoprostol; myomectomiy after administration of misoprostol 400μg PO (experimental group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Compare between experimental and control groups: Patient BMI	at inclusion
Compare between laparotomy and laparoscopy: Patient BMI	at inclusion
Compare between experimental and control groups: Patient medical history	at inclusion
Compare between laparotomy and laparoscopy: Patient medical history	at inclusion
Compare between experimental and control groups: Patient comorbidities	at inclusion
Compare between laparotomy and laparoscopy: Patient comorbidities	at inclusion
Compare between experimental and control groups: Size of myoma	at inclusion
Compare between laparotomy and laparoscopy: Size of myoma	at inclusion
Compare between experimental and control groups: FIGO classification of myoma	at inclusion
Compare between laparotomy and laparoscopy: FIGO classification of myoma	at inclusion
Compare between experimental and control groups: Number of myoma	at inclusion
Compare between laparotomy and laparoscopy: Number of myoma	at inclusion
Compare between experimental and control groups: Time between tablet intake and incision	day of surgery
Compare between laparotomy and laparoscopy: Time between tablet intake and incision	day of surgery
Compare between experimental and control groups: Total operative time	during surgery
Compare between laparotomy and laparoscopy: Total operative time	during surgery
Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells).	during surgery
Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells).	during surgery
Compare between experimental and control groups: Immediate post-operative complications	up to 8 weeks after surgery
Compare between laparotomy and laparoscopy: Immediate post-operative complications	up to 8 weeks after surgery
Compare between experimental and control groups: Pain assessments at different times: VAS (Visual analogue scale from 0 : no pain to 10 : worst pain) at h+2, h+6 D1 M1	between 2 hours after surgery until 1 month post-operative
Compare between laparotomy and laparoscopy: Pain assessments at different times: VAS (Visual analogue scale from 0 : no pain to 10 : worst pain) at h+2, h+6 D1 M1	between 2 hours after surgery until 1 month post-operative
Compare between experimental and control groups: Length of hospital stay after surgery in days	up to one week after surgery
Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days	up to one week after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Anne-Sophie GREMEAU, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): April 17, 2028

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: misoprostol; myomectomy; surgical blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Hemorrhage; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Myofibroma; Blood Loss, Surgical; Fatty Acids; Lipids; Surgical Procedures, Operative; Biological Factors; Urogenital Surgical Procedures; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Gynecologic Surgical Procedures; Prostaglandins E, Synthetic; Misoprostol; Uterine Myomectomy
• Other Study ID Numbers: RBHP 2024 GREMEAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No