Myoma;UterusHEMOMYOCNCT06882824
Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
A study testing myomectomy with misoprostol in people with Myoma;Uterus and Myomectomy; Surgical Blood Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Myoma;Uterus, Myomectomy; Surgical Blood Loss
- What is being tested?
- myomectomy with misoprostol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2025to 17 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Patients with hepatic or renal insufficiency
- Pregnancy, suspected ectopic pregnancy and breast-feeding women.
- Minors
- Guardianship, curatorship, deprived of liberty, safeguard of justice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Clermont-Ferrand, 63000
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Anne-Sophie GREMEAU
About this study
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.
Read more
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
- Being tested
- myomectomy with placebo, myomectomy with misoprostol
- Keywords
- myomectomy, surgical blood loss, misoprostol
- Medical subject headings
- Myofibroma, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomectomy with placeboProcedure or surgery
myomectomy after administration of placebo (control group)
myomectomy with misoprostolProcedure or surgery
myomectomiy after administration of misoprostol 400μg PO (experimental group)
| Study group | Role | What they receive |
|---|---|---|
| treatment arm with misoprostol | Experimental | Not described Receives: Procedure: myomectomy with misoprostol |
| Placebo arm | Placebo comparator | Not described Receives: Procedure: myomectomy with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: during surgery
Compare Hemoglobin level (in g/L) between experimental and control groups
Measured: between day before surgery and day of surgery
Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery
Measured: between day before surgery and day of surgery
Compare between experimental and control groups: Patient age
Measured: at inclusion
Compare between laparotomy and laparoscopy: Patient age
Measured: at inclusion
Compare between experimental and control groups: Patient BMI
Measured: at inclusion
Compare between laparotomy and laparoscopy: Patient BMI
Measured: at inclusion
Compare between experimental and control groups: Patient medical history
Measured: at inclusion
Compare between laparotomy and laparoscopy: Patient medical history
Measured: at inclusion
Compare between experimental and control groups: Patient comorbidities
Measured: at inclusion
Compare between laparotomy and laparoscopy: Patient comorbidities
Measured: at inclusion
Compare between experimental and control groups: Size of myoma
Measured: at inclusion
Compare between laparotomy and laparoscopy: Size of myoma
Measured: at inclusion
Compare between experimental and control groups: FIGO classification of myoma
Measured: at inclusion
Compare between laparotomy and laparoscopy: FIGO classification of myoma
Measured: at inclusion
Compare between experimental and control groups: Number of myoma
Measured: at inclusion
Compare between laparotomy and laparoscopy: Number of myoma
Measured: at inclusion
Compare between experimental and control groups: Time between tablet intake and incision
Measured: day of surgery
Compare between laparotomy and laparoscopy: Time between tablet intake and incision
Measured: day of surgery
Compare between experimental and control groups: Total operative time
Measured: during surgery
Compare between laparotomy and laparoscopy: Total operative time
Measured: during surgery
Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells).
Measured: during surgery
Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells).
Measured: during surgery
Compare between experimental and control groups: Immediate post-operative complications
Measured: up to 8 weeks after surgery
Compare between laparotomy and laparoscopy: Immediate post-operative complications
Measured: 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
Measured: 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
Measured: between 2 hours after surgery until 1 month post-operative
Compare between experimental and control groups: Length of hospital stay after surgery in days
Measured: up to one week after surgery
Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days
Measured: up to one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start12 Mar 2025
- Primary completion17 Apr 2027 (estimated)
- Study completion17 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma;UterusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie GREMEAU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882824
- Sponsor's protocol ID
- RBHP 2024 GREMEAU
- Acronym
- HEMOMYOC
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
- ClinicalTrials.gov ID
- NCT06882824
- Acronym / sponsor ID
- HEMOMYOC / RBHP 2024 GREMEAU
- Conditions
- Myoma;Uterus, Myomectomy; Surgical Blood Loss
- Keywords
- myomectomy, surgical blood loss, misoprostol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 17 Apr 2027 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment arm with misoprostol | Experimental | Procedure: myomectomy with misoprostol |
| Placebo arm | Placebo comparator | Procedure: myomectomy with placebo |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myomectomy with placebomyomectomy after administration of placebo (control group) | Procedure or surgery | Placebo arm |
| myomectomy with misoprostolmyomectomiy after administration of misoprostol 400μg PO (experimental group) | Procedure or surgery | treatment arm with misoprostol |
Primary outcome
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.
Time frame: during surgery
29 secondary outcomes
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.
Time frame: during surgery
Compare Hemoglobin level (in g/L) between experimental and control groups
Time frame: between day before surgery and day of surgery
Compare Hemoglobin level (in g/L) between laparotomy and laparoscopy surgery
Time frame: between day before surgery and day of surgery
Compare between experimental and control groups: Patient age
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Patient age
Time frame: at inclusion
Compare between experimental and control groups: Patient BMI
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Patient BMI
Time frame: at inclusion
Compare between experimental and control groups: Patient medical history
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Patient medical history
Time frame: at inclusion
Compare between experimental and control groups: Patient comorbidities
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Patient comorbidities
Time frame: at inclusion
Compare between experimental and control groups: Size of myoma
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Size of myoma
Time frame: at inclusion
Compare between experimental and control groups: FIGO classification of myoma
Time frame: at inclusion
Compare between laparotomy and laparoscopy: FIGO classification of myoma
Time frame: at inclusion
Compare between experimental and control groups: Number of myoma
Time frame: at inclusion
Compare between laparotomy and laparoscopy: Number of myoma
Time frame: at inclusion
Compare between experimental and control groups: Time between tablet intake and incision
Time frame: day of surgery
Compare between laparotomy and laparoscopy: Time between tablet intake and incision
Time frame: day of surgery
Compare between experimental and control groups: Total operative time
Time frame: during surgery
Compare between laparotomy and laparoscopy: Total operative time
Time frame: during surgery
Compare between experimental and control groups: Transfusion rate in number of RBCs (Red Blood Cells).
Time frame: during surgery
Compare between laparotomy and laparoscopy: Transfusion rate in number of RBCs (Red Blood Cells).
Time frame: during surgery
Compare between experimental and control groups: Immediate post-operative complications
Time frame: up to 8 weeks after surgery
Compare between laparotomy and laparoscopy: Immediate post-operative complications
Time frame: 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
Time frame: 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
Time frame: between 2 hours after surgery until 1 month post-operative
Compare between experimental and control groups: Length of hospital stay after surgery in days
Time frame: up to one week after surgery
Compare between laparotomy and laparoscopy: Length of hospital stay after surgery in days
Time frame: up to one week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Sophie GREMEAU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myomectomy with misoprostol in people with Myoma;Uterus and Myomectomy; Surgical Blood Loss, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_internet_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.