Optimum Misoprostol Dose Prior to Office Hysteroscopy

Phase 3CompletedNCT01612065

Cairo University132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Infertility Abnormal Uterine and Vaginal Bleeding, Unspecified Recurrent Abortion

Interventions

MisoprostolDRUG

200 ug

MisoprostolDRUG

Misoprostol vaginally, 400 ug

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kasr alainy hospital, faculty of medicine , Cairo university

Cairo, Egypt

Outcomes

Primary Outcomes

Pain score

Pain score by VAS

Time frame: 1year

Secondary Outcomes

Easiness

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;

Time frame: 1year

Duration of the procedure

Duration of hysteroscopy in seconds

Time frame: 1year

Data from ClinicalTrials.gov

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