A randomised double-blind placebo-controlled trial of oral misoprostol for cervical priming before outpatient hysteroscopy

Conditions: Abnormal uterine bleeding (hysteroscopy to investigate and treatment of abnormal uterine bleeding)

Registration Number: EUCTR2004-002051-13-GB

Lead Sponsor: Imperial College, London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 200

Inclusion Criteria

All women attending outpatient hysteroscopy clinic.
Patients who ahve given written consent for participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, Patients with endometrial thickness of less than 4mm on ultrasound scan as they do not require a hysteroscopy, Contraindications of hysteroscopy, Contraindications to prostaglandins (patients where an episode of hypotension may be precipitate problems; cardiovascular, cerebrovascular disease and peripheral vascular disease), Patients already taking misoprostol or ArthrotecË (contains 200ºg misoprostol), Cervical abnormalities (false passage, space occupying lesion in cervical canal), Presence of significant uterovaginal prolapse and Failure to obtain informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): When a total of 200 patients have been recruited. If any data is incomplete in the some patients, recruitment will continue until 200 patients have complete data.;Main Objective: Misoprostol is a prostaglandin E1 analogue that has been shown to dilate the cervix in the non-pregnant state. We hypothesize that misoprostol will improve outpatient hysteroscopy (OPH) by reducing the need to dilate the cervix, reducing pain overall, and improving the ease of the hysteroscopy.<br><br>Our primary outcome measure will be the percentage of patients that require mechanical dilatation after cervical priming.<br>;Secondary Objective: Our secondary outcome measures will be divided into two sections. Patient related findings will include pain perception and satisfaction with the procedure. Hysteroscopy related findings will cover the ease of the hysteroscope insertion, length of time to insert hysteroscope, view of uterine cavity, length of procedure, failure rate and complications.

Secondary Outcome Measures