Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Phase 3

Completed

• Conditions: Myoma;Uterus
• Interventions: Drug: Misoprostol; Drug: Dinoprostone

• Registration Number: NCT05761418
• Lead Sponsor: Beni-Suef University

Brief 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

Detailed 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

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-20
• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-07
• Last Update Submitted: 2023-03-07
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.
Dinoprostone	Dinoprostone	Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.

Primary Outcome Measures

Name	Time	Method
Blood loss	all time of the myomectomy operation	quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.

Secondary Outcome Measures

Name	Time	Method
change hemoglobin levels	within 1 week before operation and 24 hours after operation	Pre and Postoperative hemoglobin levels

Trial Locations

Locations (1)

Beni-suef university; 🇪🇬 Banī Suwayf, Egypt