Single-dose Vaginal Dinoprostone and Hysterectomy

Hysterectomy Clinical Trial

Official title:

Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080323
• Other study ID #: dinoprostone hysterectomy
• Status: Completed
• Phase: Phase 3
• Start date: September 25, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Dinoprostone 3 mg
1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
• placebo
1 vaginal tablet of placebo 60 minutes before surgery

Locations

Country	Name	City	State
Egypt	Ahmed Samy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease blood loss during hysterectomy	decrease blood loss during hysterectomy in ml	intraoperative
Secondary	postoperative hemoglobin level	postoperative hemoglobin level in gm/dl	24 hours