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Optimum Misoprostol Dose Prior to Office Hysteroscopy

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Misoprostol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Office hysteroscopy, Cervical priming, Misoprostol

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Kasr alainy hospital, faculty of medicine , Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Misoprostol vaginally, 200 ug

Misoprostol vaginally, 400ug

Arm Description

200 ug misoprostol in the posterior vaginal fornix

Misoprostol in the posterior vaginal fornix

Outcomes

Primary Outcome Measures

Pain score
Pain score by VAS

Secondary Outcome Measures

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;
Duration of the procedure
Duration of hysteroscopy in seconds

Full Information

First Posted
May 28, 2012
Last Updated
April 10, 2013
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01612065
Brief Title
Optimum Misoprostol Dose Prior to Office Hysteroscopy
Official Title
The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Abnormal Uterine and Vaginal Bleeding, Unspecified, Recurrent Abortion
Keywords
Office hysteroscopy, Cervical priming, Misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol vaginally, 200 ug
Arm Type
Active Comparator
Arm Description
200 ug misoprostol in the posterior vaginal fornix
Arm Title
Misoprostol vaginally, 400ug
Arm Type
Active Comparator
Arm Description
Misoprostol in the posterior vaginal fornix
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
200 ug
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprostol vaginally, 400 ug
Primary Outcome Measure Information:
Title
Pain score
Description
Pain score by VAS
Time Frame
1year
Secondary Outcome Measure Information:
Title
Easiness
Description
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;
Time Frame
1year
Title
Duration of the procedure
Description
Duration of hysteroscopy in seconds
Time Frame
1year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-khayat, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr alainy hospital, faculty of medicine , Cairo university
City
Cairo
ZIP/Postal Code
12211
Country
Egypt

12. IPD Sharing Statement

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