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Study on Reducing Bleeding Risk in Fibroid Surgery Using Misoprostol for Patients Undergoing Myomectomy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Misoprostol in patients undergoing surgery for fibroids, which are non-cancerous growths in the uterus. The study aims to see if Misoprostol can help reduce blood loss during these surgeries. Participants in the study will be divided into two groups: one group will receive Misoprostol, and the other group will receive a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how Misoprostol affects blood loss during the surgical removal of fibroids, known as a myomectomy. Participants will take the medication or placebo before their surgery, and researchers will measure the amount of blood lost during the procedure. The study will also look at other factors, such as changes in hemoglobin levels, which is a protein in red blood cells that carries oxygen, and the length of hospital stay after surgery.

Throughout the study, researchers will compare the results between the group taking Misoprostol and the group taking the placebo. This will help determine if Misoprostol is effective in reducing blood loss and improving outcomes for patients undergoing myomectomy for fibroids. The study is expected to continue until December 2026, with recruitment starting in October 2024.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age (18 to 43 years), presence of symptomatic myomas (fibroids), and the need for a myomectomy (surgical removal of fibroids).

2 randomization

Participants are randomly assigned to one of two groups: the experimental group receiving misoprostol or the control group receiving a placebo.

3 medication administration

Participants in the experimental group receive a single dose of misoprostol 400 micrograms orally. Participants in the control group receive a placebo tablet.

4 surgical procedure

The surgical procedure, myomectomy, is performed. The type of surgery (laparoscopy or laparotomy) depends on the size and number of fibroids.

5 intraoperative assessment

During surgery, blood loss is measured in milliliters by assessing the volume in suction devices and blood-soaked compresses.

6 postoperative evaluation

Postoperative evaluations include comparing hemoglobin levels before and after surgery, and at one month post-surgery. Other factors such as demographic characteristics, fibroid characteristics, and early postoperative complications are also assessed.

7 follow-up

Follow-up assessments occur at specified intervals to monitor recovery and any complications. The length of hospitalization and recovery progress are documented.

Who Can Join the Study?

  • Patient must be a woman aged between 18 and 43 years old.
  • Patient must have symptomatic myomas, which means fibroids causing symptoms like bleeding, pain, or difficulty getting pregnant.
  • If the patient needs a myomectomy (surgery to remove fibroids) by laparoscopy (a type of surgery done through small cuts), the fibroid should be 10 cm or smaller, or there should be 4 or fewer fibroids.
  • If the patient needs a myomectomy by laparotomy (a type of surgery done through a larger cut), the fibroid should be larger than 10 cm, or there should be more than 4 fibroids.
  • It must be possible to perform OTAU during the surgery, which involves placing a clip on the uterine artery and using a special device called a turnstile.

Who Cannot Join the Study?

  • Participants must not have any other medical conditions that could interfere with the study.
  • Participants must not be pregnant or breastfeeding.
  • Participants must not have a history of allergic reactions to the study medication.
  • Participants must not be taking any medications that could interfere with the study results.
  • Participants must not have any significant health issues that could pose a risk during the study.
  • Participants must not have participated in another clinical trial recently.
  • Participants must not have a history of substance abuse.
  • Participants must not have any mental health conditions that could affect their ability to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.10.2024

Trial locations

Investigated drugs:

Misoprostol is a medication used in this clinical trial to help reduce the risk of bleeding during a surgical procedure called myomectomy. Myomectomy is a surgery to remove fibroids from the uterus. In this study, misoprostol is given to patients to see if it can help decrease the amount of blood lost during the surgery.

Fibroma – Fibroma is a benign tumor composed mainly of fibrous or connective tissue. It typically develops in the uterus, skin, or other organs. These growths are usually non-cancerous and can vary in size. They may cause symptoms depending on their location and size, such as discomfort or pressure on nearby organs. Fibromas grow slowly and may remain stable for long periods. In some cases, they may not require any intervention unless they cause significant symptoms.

Trial ID:
2024-513617-13-00
Protocol code:
RBHP 2024 GREMEAU
NCT ID:
NCT06882824
Trial Phase:
Therapeutic exploratory (Phase II)

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