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Completed

NCT Number: NCT01612065

Optimum Misoprostol Dose Prior to Office Hysteroscopy

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

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Key information

Conditions

Infertility Abnormal Uterine and Vaginal Bleeding, Unspecified Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Recurrent Abortion Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kasr alainy hospital, faculty of medicine , Cairo university

Cairo, 12211, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

200 ug

Primary outcomes

  1. Pain score

    Time frame: 1year

    Pain score by VAS

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2012
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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