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Completed

NCT Number: NCT04044079

Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo in minimizing 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

Ahmed Samy

Giza, 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) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum hemorrhage, 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 or misoprostol therapy (asthma, liver, kidney, or heart disease).

Treatment and study plan

Dinoprostone

Drug

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

Misoprostol

Drug

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

Placebo

Drug

one tablet of placebo inserted by the patient 12 hours before the scheduled office 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 Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Sep 1, 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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