CompletedPhase 1

Evaluating Efficacy of Intravenous Carbetocin Versus Intramyometrial Injection of Adrenaline in Reducing Blood Loss

Egypt62 participantsStarted 2023-02-01

Plain-language summary

Uterine fibroids, affecting 20-50% of all women ,and are benign tumors that arise from myometrial cells of the uterine smooth muscle tissue. Although most are asymptomatic, fibroids can often cause abnormal uterine bleeding, iron deficiency anemia, pelvic pressure symptoms and pain

Who can participate

Age range25 Months – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)

Timeframe: First 2 hours after abdominal myomectomy

Trial details

NCT IDNCT05986266

SponsorEgymedicalpedia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-30

View on ClinicalTrials.gov More Uterine Fibroid trials