Optimum Misoprostol Dose Prior to Office Hysteroscopy

Infertility Clinical Trial

Official title:

The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612065
• Other study ID #: 2752012
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2012
• Last updated: April 10, 2013
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Description:

The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Female patient pre- or postmenopausal undergo office hysteroscopy.

• Age: from 20 to 60.

• BMI between 18 and 30.

Exclusion Criteria:

• PID or

• Heavy uterine bleeding

• Cervical malignancy.

• Symptoms suggestive of endometriosis .

• Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Study Design

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

Related Conditions & MeSH terms

• Abnormal Uterine and Vaginal Bleeding, Unspecified
• Abortion, Habitual
• Infertility
• Recurrent Abortion

Intervention

Drug:
• Misoprostol
200 ug
• Misoprostol
Misoprostol vaginally, 400 ug

Locations

Country	Name	City	State
Egypt	Kasr alainy hospital, faculty of medicine , Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain score by VAS	1year	Yes
Secondary	Easiness	ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5;	1year	Yes
Secondary	Duration of the procedure	Duration of hysteroscopy in seconds	1year	Yes