Optimum Misoprostol Dose Prior to Office Hysteroscopy

Overview

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

Full Title of Study: “The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2013

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

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Misoprostol vaginally, 200 ug
    • 200 ug misoprostol in the posterior vaginal fornix
  • Active Comparator: Misoprostol vaginally, 400ug
    • Misoprostol in the posterior vaginal fornix

Clinical Trial Outcome Measures

Primary Measures

  • Pain score
    • Time Frame: 1year
    • Pain score by VAS

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Waleed El-khayat, Assistant professor of obstetrics and gynecology – Cairo University
  • Overall Official(s)
    • Waleed El-khayat, M.D., Principal Investigator, Cairo University

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