Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

NCT05761418 | Completed Phase 3

• 1 other identifier: REC-H-PhBSU-22021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Myoma;Uterus

Keywords

Uterine leiomyoma; misoprostol; dinoprostone

Outcome Measures

Primary Outcomes (1)

• Blood loss

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

  all time of the myomectomy operation

Secondary Outcomes (1)

• change hemoglobin levels

  within 1 week before operation and 24 hours after operation

Study Arms (3)

Dinoprostone

EXPERIMENTAL

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

Drug: Dinoprostone

Misoprostol

EXPERIMENTAL

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

Drug: Misoprostol

control

NO INTERVENTION

received a placebo vaginally 2 hrs. preoperatively.

Interventions

Dinoprostone DRUG

prostaglandin (PG) E2 analog

Also known as: Dinoglandin

Dinoprostone

Misoprostol DRUG

prostaglandin (PG) E1 analog

Also known as: Cytotec

Misoprostol

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 30-50 years
• all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Myofibroma

Interventions

Dinoprostone; Misoprostol

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E, Synthetic; Prostaglandins, Synthetic

Study Officials

• Beni-Suef University

  Faculty of Medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 9, 2023
• Study Start: March 1, 2018
• Primary Completion: February 15, 2023
• Study Completion: February 20, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)