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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):

May 28, 2012
June 5, 2012
April 11, 2013
June 2012
March 2013   (Final data collection date for primary outcome measure)
Pain score [ Time Frame: 1year ]
Pain score by VAS
Same as current
Complete list of historical versions of study NCT01612065 on ClinicalTrials.gov Archive Site
  • 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;
  • Duration of the procedure [ Time Frame: 1year ]
    Duration of hysteroscopy in seconds
Same as current
Not Provided
Not Provided
 
Optimum Misoprostol Dose Prior to Office Hysteroscopy
The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Infertility
  • Abnormal Uterine and Vaginal Bleeding, Unspecified
  • Recurrent Abortion
  • Drug: Misoprostol
    200 ug
  • Drug: Misoprostol
    Misoprostol vaginally, 400 ug
  • Active Comparator: Misoprostol vaginally, 200 ug
    200 ug misoprostol in the posterior vaginal fornix
    Intervention: Drug: Misoprostol
  • Active Comparator: Misoprostol vaginally, 400ug
    Misoprostol in the posterior vaginal fornix
    Intervention: Drug: Misoprostol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
April 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Egypt
 
 
NCT01612065
2752012
Not Provided
Not Provided
Not Provided
Waleed El-khayat, Cairo University
Cairo University
Not Provided
Principal Investigator: Waleed El-khayat, M.D. Cairo University
Cairo University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP