Protocol summary

Summary
This is a randomized double blind placebo-controlled clinical trial study designed to evaluate the efficacy of 400 micg of misoprostol prescript sublingual, in comparison with vaginal prescription, on cervical ripening before curative or diagnostic hysteroscopy. 100 patients were randomly assigned to the following treatment regimen . The vaginal group received 400 micg of misoprostol (placed into the posterior vaginal fornix) and at the same time received one tablet of vitamin B6 as placebo. The sublingual group received 400 micg of misoprostol sublingually and at the same time received one tablet of vitamin B6 as placebo. Duration of cervical dilatation time in with 9 hegar could be inserted and the complications of hysteroscopy (cervical tearing, creation of a false track, uterine perforation and bleeding) were interpreted as the outcome. 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 2 cm (because of partial dilatation of cervix).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012272576N3
Registration date: 2011-04-06, 1390/01/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-04-06, 1390/01/17
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research., Tehran university of medical scienes
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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).
Age
From 14 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods Ave, Tehran University of Medical Sciences
City
Tehran
Postal code
Iran
Approval date
2010-06-20, 1389/03/30
Ethics committee reference number
9724

Health conditions studied

1

Description of health condition studied
Hysteroscopy
ICD-10 code
N88.9
ICD-10 code description
Non inflammatory disorder of cervix uteri, unspecified

Primary outcomes

1

Description
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 outcomes

1

Description
complications of hysteroscopy
Timepoint
6hours after misoprostol prescription
Method of measurement
clinical

Intervention groups

1

Description
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 fornix) and at the same time recieved one tablet of vit B6 sublingualy as placebo. .
Category
Treatment - Drugs

2

Description
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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirza Kochak Khan Hospital, Tehran, Iran
Full name of responsible person
Fateme Davari Tanha
Street address
Mirza kochakkhan Hospital, Ostad nejatolahi Avenue, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research., Tehran university of medical science
Full name of responsible person
Miss Rahmani
Street address
Vice chancellor for research, Tehran University of Medical Science, Ghods Avenue, Keshavarz Blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research., Tehran university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University ofMedical Sciences
Full name of responsible person
Fateme Davari Tanha
Position
Assistant professor
Other areas of specialty/work
Street address
Mirza Kuchak Khan Hospital, Ostad Nejatolahi Ave, Tehran, Iran
City
Tehran
Postal code
15978
Phone
+98 21 8889 7761
Fax
Email
fatedavari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Davari Tanha
Position
Assistant professor
Other areas of specialty/work
Street address
Mirza Kuchak Khan Hospital, Ostad Nejatolahi Ave, Tehran, Iran
City
Tehran
Postal code
15978
Phone
+98 912 193 1231
Fax
Email
fatedavari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of medical science
Full name of responsible person
Fateme Davari tanha
Position
Assistant professor
Other areas of specialty/work
Street address
Mirza Kuchak Khan Hospital, Ostad Nejatolahi Ave, Tehran, Iran
City
Tehran
Postal code
15978
Phone
+98 219121931231
Fax
Email
fatedavari@yahoo.come
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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