Compare misoprostol and isosorbide mononitrate to soften the servix in infertile women undergoing hysteroscopy
Design
In this study, 56 infertile nulliparous women need cervical softening for undergoing surgical hysteroscopy were participated. Patients were randomly divided into two groups and the first group received 25 μg misoprostol (vaginal every 4 hours to 4 doses) and the second group received 40 mg of isosorbide mononitrate (vaginal every 6 hours to 2 doses).
Settings and conduct
Samples are selected among available patients in the hospital, which are entered into the study sequentially
Participants/Inclusion and exclusion criteria
Infertile women undergoing hysteroscopy
Intervention groups
Patients entering the study were randomly divided into two groups. The first group received misoprostol at 25 micrograms (vaginal every 4 hours to 4 doses) and the second group received isosorbide mononitrate 40 mg (vaginal every 6 hours to two doses).
Main outcome variables
Headache; abdominal pain; nausea and vomiting; heart rate; respiratory rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180826040879N1
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Yasin Ganjali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 2223 5605
Email address
yasin.ganjali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-14, 1396/02/24
Expected recruitment end date
2017-11-23, 1396/09/02
Actual recruitment start date
2017-05-14, 1396/02/24
Actual recruitment end date
2018-11-23, 1397/09/02
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Compare misoprostol and isosorbide mononitrate to soften the servix for infertile women undergonig histroscopy
Public title
Compare misoprostol and isosorbide mononitrate to soften the servix for infertile women undergonig histroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infertile wemen undergoing histroscopy
Exclusion criteria:
This study is conducted on infertile women undergoing hysteroscopic surgery
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual random sampling was done using a random number table. َAccording to the size of the community which was 56 people, we chose a random start point to select the units. Finally, we started the selection from this point and considered each number smaller than or equal to 56 as the sample.Even numbers were assigned to misopristol group and odd numbers were assigned to isosorbide group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zabol University of Medical Sciences Ethics Committee
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.ZBMU.REC.1397.059
Health conditions studied
1
Description of health condition studied
Comparison of the effect of misoprostol and isosorbide mononitrate on cervix
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Study of headache after taking misoprostol and isosorbide mononitrate on cervix
Timepoint
Headache in the beginning of the study after taking Misoprostol and isosorbide mononitrate on the cervix
Method of measurement
Asking questions from the patient himself
2
Description
Study of nausea and vomiting after taking misoprostol and isosorbide mononitrate on cervix
Timepoint
Nausea and vomiting at the beginning of the study following the use of Mizo, Prostol and Isosorbide Mononitrate on the cervix
Method of measurement
Asking questions from the patient himself
3
Description
Evaluation of abdominal pain after taking misoprostol and isosorbide mononitrate on the cervix
Timepoint
ََAbdominal painat the beginning of the study following the use of Mizo, Prostol and Isosorbide Mononitrate on the cervix
Method of measurement
Asking questions from the patient himself
4
Description
Evaluation of cervical dilatation after taking misoprostol and isosorbide mononitrate
Timepoint
Study of cervical dilatation rate at the beginning of study after misoprostol and isosorbide mononitrate
Method of measurement
Respectively, using small to large bogies
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group received 25 μg misoprostol (vaginal every 4 hours to 4 doses)
Category
Treatment - Drugs
2
Description
Control group: 60 mg isosorbine mononitrate suppository every 6 hours until two doses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zabol Amir Al Momenin hospital
Full name of responsible person
Zahra Shahraki
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2187
Email
zahra.shahraki@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zahra Shahraki
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2191
Email
zahra.shahraki@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zahra Shahraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2191
Email
zahra.shahraki@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Zahra shahraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2191
Email
zahra.shahraki@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
ZAhra Shahraki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zabol - Shahid Rajaee Street - Educational Complex
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Phone
+98 54 3223 2191
Email
zahra.shahraki@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD