Single-dose Vaginal Dinoprostone and Hysterectomy

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Hysterectomy

Treatments: Drug: Dinoprostone 3 mg; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04080323

dinoprostone hysterectomy

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

dinoprostone 3 mg

Experimental group

Description:

60 minutes before the surgery 3 mg of dinoprostone inserted vaginally

Treatment:

Drug: Dinoprostone 3 mg

placebo

Placebo Comparator group

Description:

60 minutes before the surgery 1 tablet of placebo inserted vaginally

Treatment:

Drug: placebo