Misoprostol Prior to Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain

Pain Clinical Trial

Official title:

Cervical Priming With Misoprostol Before Diagnostic Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain. A Randomized Double Blinded Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02318225
• Other study ID #: Miso/Placebo/hystero1
• Status: Recruiting
• Phase: Phase 2
• First received: December 11, 2014
• Last updated: September 19, 2015
• Start date: January 2015
• Est. completion date: October 2015

Study information

• Verified date: September 2015
• Source: Cairo University
• Contact: Usama M Fouda, M.D,PhD
• Phone: 01095401375
• Email: umfrfouda[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Description:

Cervical ripening with misoprostol to minimize the pain experienced during office hysteroscopy has been proposed by several authors.

The use of misoprostol is usually associated with undesired side effects and therefore any beneficial effect of misoprostol on reducing pain should be weighed against its undesired side effects (nausea, vomiting, diarrhea, fever, shivering, pain) and coasts. Till now , no studies have yet determined whether misoprostol should be used routinely or for the subgroup of patients at higher risk for cervical stenosis.

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients with at least one vaginal delivery who have an indication for office hysteroscopy.

Exclusion Criteria:

• Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean section or cervical surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Misoprostol
Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens 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).
• Placebo
Placebo will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens 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).

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department,Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Cicinelli E, Rossi AC, Marinaccio M, Matteo M, Saliani N, Tinelli R. Predictive factors for pain experienced at office fluid minihysteroscopy. J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):485-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of pain		procedure	No
Secondary	Operative time		procedure	No