Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

March 7, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dinoprostone
Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.
Drug: Dinoprostone
prostaglandin (PG) E2 analog
Other Names:
  • Dinoglandin
Experimental: Misoprostol
will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.
Drug: Misoprostol
prostaglandin (PG) E1 analog
Other Names:
  • Cytotec
No Intervention: control
received a placebo vaginally 2 hrs. preoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: all time of the myomectomy operation
quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.
all time of the myomectomy operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change hemoglobin levels
Time Frame: within 1 week before operation and 24 hours after operation
Pre and Postoperative hemoglobin levels
within 1 week before operation and 24 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Beni-Suef University, Faculty of medicine Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-H-PhBSU-22021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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