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Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Sponsor
Beni-Suef University (Other)
Overall Status
Completed
CT.gov ID
NCT05761418
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
59.7
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Feb 15, 2023
Actual Study Completion Date :
Feb 20, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Blood loss [all time of the myomectomy operation]

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

    Secondary Outcome Measures

    1. change hemoglobin levels [within 1 week before operation and 24 hours after operation]

      Pre and Postoperative hemoglobin levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-suef university Banī Suwayf Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05761418
    Other Study ID Numbers:
    • REC-H-PhBSU-22021
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 9, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sara Abdallah Mohamed Salem, Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University, Beni-Suef University
    Uterine leiomyoma
    misoprostol
    dinoprostone
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Misoprostol
    Dinoprostone

    Study Results

    No Results Posted as of Mar 9, 2023