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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002051-13-GB

Enrollment

200

Registered

2005-07-21

Start date

2005-08-17

Completion date

Unknown

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Cytotec Product Name: cytotec Pharmaceutical Form: Capsule* INN or Proposed INN: Misoprostol CAS Number: 59122-46-2 Current Sponsor code: PANN 3006 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. Our primary outcome measure will be the percentage of patients that require mechanical dilatation after cervical priming. ;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.	—

Measure

Time frame

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. Our primary outcome measure will be the percentage of patients that require mechanical dilatation after cervical priming. ;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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026