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NCT Number: NCT02328495

Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Obstetrics and Gynecology Department,Cairo university

Cairo, Cairo Governorate, Egypt

About this study

Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Menopausal patients who have an indication for office hysteroscopy

Exclusion criteria

  • Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Treatment and study plan

Misoprostol

Drug

Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.

Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

bladder filling

Other

Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic.

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

Primary outcomes

  1. Intensity of pain [ visual analogue scale ranging from 0 to 10 ]

    Time frame: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure

Secondary outcomes

  1. Operative time

    Time frame: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2014
Registry last updated
Jul 27, 2016

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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