Single-dose Vaginal Dinoprostone and Hysterectomy
- Registration Number
- NCT04080323
- Lead Sponsor
- Cairo University
- 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 be due to the combined effect of myometrial contraction and vasoconstrictive effect
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 118
Inclusion Criteria
-
• 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 Criteria
-
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dinoprostone 3 mg Dinoprostone 3 mg 60 minutes before the surgery 3 mg of dinoprostone inserted vaginally placebo placebo 60 minutes before the surgery 1 tablet of placebo inserted vaginally
- Primary Outcome Measures
Name Time Method decrease blood loss during hysterectomy intraoperative decrease blood loss during hysterectomy in ml
- Secondary Outcome Measures
Name Time Method postoperative hemoglobin level 24 hours postoperative hemoglobin level in gm/dl
Trial Locations
- Locations (1)
Ahmed Samy
🇪🇬Giza, Egypt