Single-dose Vaginal Dinoprostone and Hysterectomy

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

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

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: Dinoprostone 3 mg; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11231
    • Ahmed Samy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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; 60 minutes before the surgery 3 mg of dinoprostone inserted vaginally	Drug: Dinoprostone 3 mg; 1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
Placebo Comparator: placebo; 60 minutes before the surgery 1 tablet of placebo inserted vaginally	Drug: placebo; 1 vaginal tablet of placebo 60 minutes before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease blood loss during hysterectomy	decrease blood loss during hysterectomy in ml	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative hemoglobin level	postoperative hemoglobin level in gm/dl	24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: AHMED SAMY, Cairo University; Principal Investigator: ayman taher, MD, Cairo University; Principal Investigator: ahmed S Ali, Faculty of Medicine Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 30, 2020

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): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

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 hysterectomy

Drug and device information, study documents

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