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Compares treatment options for Myoma;Uterus
Official title Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy
ClinicalTrials.gov ID: NCT07390864
What this study is testing
What is Methylergometrine (Intramyometrial Injection)?
Methylergometrine (Intramyometrial Injection) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for myoma;uterus.
Also referred to as Methylergometrine maleate, Ergometrine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized clinical trial is to determine whether intramyometrial ergometrine injection or intramyometrial carbetocin injection is more effective in reducing blood loss during and after abdominal myomectomy in women undergoing surgery for symptomatic uterine fibroids. The main questions it aims to answer are: Does intramyometrial ergometrine reduce intraoperative and postoperative blood loss during abdominal myomectomy?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 48, women only
You may be able to join if
- Female participants aged 25 to 48 years
- Body mass index (BMI) \< 35 kg/m²
- Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms)
- Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging
- Maximum diameter of the largest myoma ≤ 20 cm
You likely can't join if
- FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
- History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
- History of prior uterine surgery
- Use of hormonal treatment within 3 months prior to enrollment
- Contraindication to methylergometrine or carbetocin, including:
- Known drug allergy
See the full eligibility criteria
- Female participants aged 25 to 48 years
- Body mass index (BMI) \< 35 kg/m²
- Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms)
- Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging
- Maximum diameter of the largest myoma ≤ 20 cm
- Eligible for and scheduled to undergo abdominal myomectomy
- Able and willing to provide written informed consent
- FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
- History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
- History of prior uterine surgery
- Use of hormonal treatment within 3 months prior to enrollment
- Contraindication to methylergometrine or carbetocin, including:
- Known drug allergy
- Hypertension
- Cardiac or pulmonary disease
- Chronic endocrine or metabolic disease (e.g., diabetes mellitus)
- Renal or hepatic impairment
- High risk of bleeding, including:
- Known bleeding disorders
- Current use of antiplatelet or anticoagulant therapy
- Preoperative anemia (hemoglobin \< 10 g/dL)
- BMI ≥ 35 kg/m²
- Intraoperative conversion from myomectomy to hysterectomy
The study team makes the final eligibility decision.
Where it's taking place
- Al Fayyum, Faiyum Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 48 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Fayyum, Faiyum Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.