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Optimum Misoprostol Dose Prior to Office Hysteroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waleed El-khayat, Cairo University
ClinicalTrials.gov Identifier:
NCT01612065
First received: May 28, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Pain score [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
    Pain score by VAS


Secondary Outcome Measures:
  • Easiness [ Time Frame: 1year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Duration of hysteroscopy in seconds


Enrollment: 132
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 28, 2012
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cairo University:
Office hysteroscopy
Cervical priming
Misoprostol

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

ClinicalTrials.gov processed this record on May 16, 2013