Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Myomectomy
• Intervention / Treatment: Drug: Dinoprostone 3 mg; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dinoprostone 3 mg; patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery	Drug: Dinoprostone 3 mg; the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
Placebo Comparator: placebo; patients will take 1 tablet of placebo 1 hour before the surgery	Drug: placebo; the patient will take one vaginal tablet of placebo 1 hour before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean amount of intraoperative blood loss	Mean amount of intraoperative blood loss in ml	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of hemoglobin after surgery	Change of hemoglobin(g/dl) after surgery	24 hours

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 10, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 10, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: dinoprostone myomectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No