Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

Myomectomy Clinical Trial

Official title:

the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04080375
• Other study ID #: dinoprostone myomectomy
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 10, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 10, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

• Age = 18 years and = 50 years

• Pre-operative hemoglobin >8 g/dl

• Ability to understand and the willingness to sign a written informed consent.

• Admissible medical/surgical history

• Five or less symptomatic uterine myomas

• All myomas are subserous or intramural.

• Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

• • Patients who have had a prior abdominal myomectomy

• Post-menopausal women

• Patients with known bleeding/clotting disorders

• Patients with a history of gynecologic malignancy

• Hypertension.

• Cardiac and Pulmonary diseases.

• Obesity (body mass index > 30 kg/m2).

• History of allergic reactions attributed to misoprostol

• Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Related Conditions & MeSH terms

• Myomectomy

Intervention

Drug:
• Dinoprostone 3 mg
the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
• placebo
the patient will take one vaginal tablet of placebo 1 hour before surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean amount of intraoperative blood loss	Mean amount of intraoperative blood loss in ml	intraoperative
Secondary	Change of hemoglobin after surgery	Change of hemoglobin(g/dl) after surgery	24 hours