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Randomized double blind placebo-controlled clinical trial comparison vaginal with sublingual misoprostol in preoperative ripening of the cervix before operative -diagnostic hysteroscopy in premenopausal women in Mirzakuchak-khan hospital at 2010-2011

Randomized double blind placebo-controlled clinical trail comparison vaginal with sublingual misoprostol in preoperative ripening of the cervix before operative -diagnostic hystroscopy in premenopausal women in mirzakuchak-khan hospital at 2010-2011

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201012272576N3
Enrollment
100
Registered
2011-04-06
Start date
2010-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Hysteroscopy. Non inflammatory disorder of cervix uteri, unspecified

Interventions

Intervention 1: 100 patients were randomly assigned to the following treatment regiment . The vaginal group recieved 400micg of misoprostol one time six hours before hysteroscopy (placed into the post
Treatment - Drugs
100 patients were randomly assigned to the following treatment regiment . The vaginal group recieved 400micg of misoprostol one time six hours before hysteroscopy (placed into the posterior vaginal f
The sublingual group received 400micg of misoprstol sublingually one time six hours before hysteroscopy and at the same time received one tablet of vitB6 as placebo

Sponsors

Vice chancellor for research., Tehran university of medical science
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
14 Years to 50 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria: woman who gave consent for operative-diagnostic hysteroscopy; and were of reproductive age (i.e.; were premenopausal) ; and not pregnant at the time of presentation." The exclusion criteria: contraindication to PGs (history of severe asthma; glaucoma; preexisting cardiac disease; hypertension, or renal failure); significant uterovaginal prolapsed precluding the administration of vaginal tablets; or history of cervical surgery or cervical incompetency; women who had sub mucosal fibroma larger than 2cm (because of partial dilatation of cervix).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration of cervical dilatation time in with 9 hegar could be inserted after prescription of sublingual or vaginal misoprostol. Timepoint: 6houres after prescription of sublingual or vaginal misoprostol. Method of measurement: The largest hegar that could be passed without resistance was starting time of dilatation.

Secondary

MeasureTime frame
Complications of hysteroscopy. Timepoint: 6hours after misoprostol prescription. Method of measurement: clinical.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Davari Tanha

Tehran University ofMedical Sciences

fatedavari@yahoo.com+98 21 8889 7761

Outcome results

None listed

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