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NCT05761418 Clinical Trial

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Myoma;Uterus Clinical Trial

Official title:
Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05761418
Other study ID # REC-H-PhBSU-22021
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 1, 2018
Est. completion date February 20, 2023

Study information
Verified date March 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

Description:

Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy. Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 20, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - Age 30-50 years - all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy. Exclusion Criteria: - contraindications to dinoprostone or misoprostol, - active PID, - history of pelvic/ ovarian endometriosis, - females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dinoprostone
prostaglandin (PG) E2 analog
• Misoprostol
prostaglandin (PG) E1 analog

Locations
Country Name City State
Egypt Beni-suef university Bani Suwayf

Sponsors (1)
Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood loss quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze. all time of the myomectomy operation
Secondary change hemoglobin levels Pre and Postoperative hemoglobin levels within 1 week before operation and 24 hours after operation
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