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Completed

NCT Number: NCT03683914

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

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Key information

Conditions

Office Hysteroscopy

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Cairo University

Cairo, 11231, Egypt

About this study

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

Exclusion criteria

  • • Nulliparous patients
  • patients with cervical pathology
  • retroverted uterus (detected by transvaginal ultrasound)
  • previous cervical surgery
  • patients with severe vaginal bleeding
  • allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease).

Treatment and study plan

Dinoprostone 3Mg Vaginal Tablet

Drug

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

placebo vaginal tablet

Drug

1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

Primary outcomes

  1. Intensity of pain

    Time frame: an expected average of 10 minutes

    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary outcomes

  1. Intensity of pain

    Time frame: 30 minutes after the procedure

    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10

  2. Operative time

    Time frame: an expected average 10 minutes

    From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2018
Registry last updated
Mar 26, 2019

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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