Status:
UNKNOWN
Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy
Lead Sponsor:
Cairo University
Conditions:
Myomectomy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04080375
Start Date
September 10 2019
End Date
December 10 2019
Last Update
September 6 2019
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