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Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy

Optimal Timing of Misoprostol Administration Prior to Office Hysteroscopy; a Randomized Controlled Trial.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02316301
Enrollment
120
Registered
2014-12-12
Start date
2015-01-31
Completion date
2015-12-31
Last updated
2016-07-27

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

Conditions

Pain

Keywords

Misoprostol, pain, office hysteroscopy

Brief summary

The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy.

Detailed description

The interval between misoprostol administration and office hysteroscopy may have an influence on its effectiveness in pain reduction. There are limited data on the optimal interval from administration of misoprostol and office hysteroscopy. In previous studies, time interval from administration of misoprostol and office hysteroscopy ranged between 2 hours and 24 hours. Till now no studies have yet investigated the optimal timing of misoprostol administration prior to office hysteroscopy or operative hysteroscopy. The aim of this study was to determine whether misoprostol administered 12 hours before office hysteroscopy can relieve pain more effectively compared with misoprostol administered 3 hours before office hysteroscopy

Interventions

DRUGLong interval misoprostol

A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

DRUGShort interval misoprostol

A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Nulliparous patients who have an indication for office hysteroscopy

Exclusion criteria

* Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, acute pelvic inflammatory disease, glaucoma, allergy to misoprostol, cardiac, liver or kidney diseases

Design outcomes

Primary

MeasureTime frame
Intensity of painup to 30 minutes

Secondary

MeasureTime frame
Duration of procedureintraoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026