Single-dose Vaginal Dinoprostone and Hysterectomy

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Dinoprostone

Criteria

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.