Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05986266
Eligibility Criteria:
Inclusion Criteria:
* Women aged 25-50 years old.
* Women who will undergo abdominal myomectomy because of symptomatic stage 3-6 fibroids, according to FIGO staging (Laughlin-Tommaso et al., 2017), with the number of myomas not exceeding five based on the preoperative ultrasonography (US).
Exclusion Criteria:
* Women with previous myomectomy.
* Pregnant and postmenopausal women.
* Women with preoperative hemoglobin concentration \<10 g/dL,
* women who are candidate for and choosing vaginal or laparoscopic myomectomy.
* History of preoperative embolization or hormone therapy (GnRH analogues), cervical and broad ligament myoma, number of myomas more than five on preoperative US, myoma FIGO stages 1,2,7 and 8 (Munro et al., 2011)
* Patients with allergy or contraindications to carbetocin or epinephrine, such as coronary artery disease, asthma, epilepsy, migraine, kidney, and hepatic disease.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Months
Maximum Age:
50 Years
Study:
NCT05986266
Study Brief:
Protocol Section:
NCT05986266