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Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Primary Purpose

Myoma;Uterus

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Dinoprostone

Misoprostol

About this trial

This is an interventional prevention trial for Myoma;Uterus focused on measuring Uterine leiomyoma, misoprostol, dinoprostone

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Beni-suef university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Dinoprostone

Misoprostol

control

Arm Description

Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.

will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.

received a placebo vaginally 2 hrs. preoperatively.

Outcomes

Primary Outcome Measures

Blood loss

quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.

Secondary Outcome Measures

change hemoglobin levels

Pre and Postoperative hemoglobin levels

Full Information

NCT ID

NCT05761418

First Posted

February 23, 2023

Last Updated

March 7, 2023

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT05761418

Brief Title

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Official Title

Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

February 15, 2023 (Actual)

Study Completion Date

February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myoma;Uterus

Keywords

Uterine leiomyoma, misoprostol, dinoprostone

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dinoprostone

Arm Type

Experimental

Arm Description

Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.

Arm Title

Misoprostol

Arm Type

Experimental

Arm Description

will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.

Arm Title

control

Arm Type

No Intervention

Arm Description

received a placebo vaginally 2 hrs. preoperatively.

Intervention Type

Drug

Intervention Name(s)

Dinoprostone

Other Intervention Name(s)

Dinoglandin

Intervention Description

prostaglandin (PG) E2 analog

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Cytotec

Intervention Description

prostaglandin (PG) E1 analog

Primary Outcome Measure Information:

Title

Blood loss

Description

quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.

Time Frame

all time of the myomectomy operation

Secondary Outcome Measure Information:

Title

change hemoglobin levels

Description

Pre and Postoperative hemoglobin levels

Time Frame

within 1 week before operation and 24 hours after operation

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beni-Suef University

Organizational Affiliation

Faculty of Medicine Beni-Suef University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beni-suef university

City

Banī Suwayf

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

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