the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Abdominal Myomectomy

Treatments: Drug: carbetocin 100 mcg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04083625

Myomectomy uterotonic

Details and patient eligibility

About

To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy

Enrollment: 138 patients

Sex: Female

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

  • Age ≥ 25 years and ≤ 50 years
  • Pre-operative hemoglobin >10 g/dl
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history
  • Five or less symptomatic uterine myomas
  • symptomatic stage 3 to 6 fibroids, according to FIGO staging

Exclusion criteria

• • Post-menopausal women

  • Patients with known bleeding/clotting disorders
  • Patients with a history of gynecologic malignancy
  • Hypertension.
  • Cardiac and Pulmonary diseases.
  • History of allergic reactions attributed to carbetocin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

carbetocin

Experimental group

Description:

100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.

Treatment:

Drug: carbetocin 100 mcg

placebo

Placebo Comparator group

Description:

10 cm syringe normal saline IV given just before skin incision of myomectomy.

Treatment:

Drug: placebo