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OpenTrials
Completed

NCT Number: NCT04080323

Single-dose Vaginal Dinoprostone and Hysterectomy

In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Samy

Giza, 11231, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Patients presenting for hysterectomy for any benign indication including uterine fibroids.
  • Age ≥ 18 years
  • Pre-operative hemoglobin >8 g/dl
  • Willing to have dinoprostone or a placebo prior to hysterectomy
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion criteria

  • • Patients with known or suspected endometrial/ovarian/cervical cancer.
  • Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
  • Patients currently undergoing treatment for any type of cancer.
  • Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
  • History of allergic reactions to dinoprostone.

Treatment and study plan

Dinoprostone 3 mg

Drug

1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery

Placebo

Drug

1 vaginal tablet of placebo 60 minutes before surgery

Primary outcomes

  1. decrease blood loss during hysterectomy

    Time frame: intraoperative

    decrease blood loss during hysterectomy in ml

Secondary outcomes

  1. postoperative hemoglobin level

    Time frame: 24 hours

    postoperative hemoglobin level in gm/dl

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Aug 27, 2020

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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