Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Myomectomy

Treatments: Drug: Dinoprostone 3 mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04080375

dinoprostone myomectomy

Details and patient eligibility

About

The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

  • Age ≥ 18 years and ≤ 50 years
  • Pre-operative hemoglobin >8 g/dl
  • Ability to understand and the willingness to sign a written informed consent.
  • Admissible medical/surgical history
  • Five or less symptomatic uterine myomas
  • All myomas are subserous or intramural.
  • Uterine size less than 24 weeks pregnancy

Exclusion criteria

• • Patients who have had a prior abdominal myomectomy

  • Post-menopausal women
  • Patients with known bleeding/clotting disorders
  • Patients with a history of gynecologic malignancy
  • Hypertension.
  • Cardiac and Pulmonary diseases.
  • Obesity (body mass index > 30 kg/m2).
  • History of allergic reactions attributed to misoprostol
  • Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

dinoprostone 3 mg

Experimental group

Description:

patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery

Treatment:

Drug: Dinoprostone 3 mg

placebo

Placebo Comparator group

Description:

patients will take 1 tablet of placebo 1 hour before the surgery

Treatment:

Drug: placebo