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Completed

NCT Number: NCT05761418

Preoperative Vaginal Dinoprostone Versus Misoprostone in 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

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beni-suef university

Banī Suwayf, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dinoprostone

Drug

prostaglandin (PG) E2 analog

Other names: Dinoglandin

Misoprostol

Drug

prostaglandin (PG) E1 analog

Other names: Cytotec

Primary outcomes

  1. 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.

Secondary outcomes

  1. change hemoglobin levels

    Time frame: within 1 week before operation and 24 hours after operation

    Pre and Postoperative hemoglobin levels

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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