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Optimum Misoprostol Dose Prior to Office Hysteroscopy

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ClinicalTrials.gov Identifier: NCT01612065
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Infertility Abnormal Uterine and Vaginal Bleeding, Unspecified Recurrent Abortion Drug: Misoprostol Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
Study Start Date : June 2012
Primary Completion Date : March 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Misoprostol vaginally, 200 ug
200 ug misoprostol in the posterior vaginal fornix
Drug: Misoprostol
200 ug
Active Comparator: Misoprostol vaginally, 400ug
Misoprostol in the posterior vaginal fornix
Drug: Misoprostol
Misoprostol vaginally, 400 ug


Outcome Measures

Primary Outcome Measures :
  1. Pain score [ Time Frame: 1year ]
    Pain score by VAS


Secondary Outcome Measures :
  1. Easiness [ Time Frame: 1year ]
    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;

  2. Duration of the procedure [ Time Frame: 1year ]
    Duration of hysteroscopy in seconds


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612065


Locations
Egypt
Kasr alainy hospital, faculty of medicine , Cairo university
Cairo, Egypt, 12211
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Waleed El-khayat, M.D. Cairo University
More Information

Responsible Party: Waleed El-khayat, Assistant professor of obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT01612065     History of Changes
Other Study ID Numbers: 2752012
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by Waleed El-khayat, Cairo University:
Office hysteroscopy
Cervical priming
Misoprostol

Additional relevant MeSH terms:
Infertility
Uterine Hemorrhage
Abortion, Habitual
Metrorrhagia
Genital Diseases, Male
Genital Diseases, Female
Uterine Diseases
Hemorrhage
Pathologic Processes
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics