Status:
COMPLETED
Single-dose Vaginal Dinoprostone and Hysterectomy
Lead Sponsor:
Cairo University
Conditions:
Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may b...
Eligibility Criteria
Inclusion
- • Patients presenting for hysterectomy for any benign indication including uterine fibroids.
- Age ≥ 18 years
- Pre-operative hemoglobin \>8 g/dl
- Willing to have dinoprostone or a placebo prior to hysterectomy
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- • Patients with known or suspected endometrial/ovarian/cervical cancer.
- Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
- Patients currently undergoing treatment for any type of cancer.
- Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
- History of allergic reactions to dinoprostone.
Key Trial Info
Start Date :
September 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04080323
Start Date
September 25 2019
End Date
June 30 2020
Last Update
August 27 2020
Active Locations (1)
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1
Ahmed Samy
Giza, Egypt, 11231