Single-dose Vaginal Dinoprostone and Hysterectomy

Cairo University118 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

118

Conditions

Hysterectomy

Interventions

Dinoprostone 3 mgDRUG

1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery

placeboDRUG

1 vaginal tablet of placebo 60 minutes before surgery

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ahmed Samy

Giza, Egypt

Outcomes

Primary Outcomes

decrease blood loss during hysterectomy

decrease blood loss during hysterectomy in ml

Time frame: intraoperative

Secondary Outcomes

postoperative hemoglobin level

postoperative hemoglobin level in gm/dl

Time frame: 24 hours

Data from ClinicalTrials.gov

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