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Comparative effect of nitroglycerin and misoprostol on cervical ripening before hysteroscopy

Protocol summary

Study aim
Determination of the comparative effect of nitroglycerin and mesoprostol in cervical preparation before hysteroscopy
Design
Two parellel group randomised Trial with doubleblinded outcome assesment
Settings and conduct
Questionar rasool akram hospital/ For the first intervention group (42 patients) pearl nitroglycerin 0.4 mg in the recovery room from half to one hour before surgery to a maximum of 3 pearls every 5 minutes with the permission of an anesthesiologist will be implanted vaginally in the posterior cervix fornix For the second intervention group (42 patients), a vaginal misoprostol 200 microgram tablet is inserted in the posterior fornix 4 to 6 hours before surgery and the rate of cervical ripening is checked with bouji and probable sideeffects are recorded
Participants/Inclusion and exclusion criteria
The informed consent of the patient, women of hysteroscopy, lack of nitroglycerin sensitivity, lack of cardiovascular diseases, unstable state of patient/Exclusion criteria:Patients with systolic blood pressure less than 100 mm Hg, intravascular volume reduction, heart disease, severe bleeding, multiparous (Gravid ≥2 NVD), inability to use nitroglycerin based on the anesthesiologist's sensitivity to any preservative, history of cerebral hemorrhage, anemia, glaucoma, hyperthyroidism, heart problems
Intervention groups
Two types of intervention are considered The first intervention group (42 patients) Pearl nitroglycerin 0.4 mg in the recovery room one to half hour before the operation up to a maximum of 3 pearls every 5 minutes with the permission of the anesthesiologist will be implanted vaginally in the posterior cervical fornix and For the second intervention group (42 patients), a misoprostol 200 microgram tablet is inserted in the posterior fornix 6hour before Operation
Main outcome variables
Measurment of dilation before hysteroscopy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220203053929N1
Registration date: 2022-04-20, 1401/01/31
Registration timing: prospective

Last update: 2022-04-20, 1401/01/31
Update count: 0
Registration date
2022-04-20, 1401/01/31
Registrant information
Name
Melika Ansarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4465 7764
Email address
melika.ansarin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of nitroglycerin and misoprostol on cervical ripening before hysteroscopy
Public title
Comparative effect of nitroglycerin and misoprostol on cervical ripening before hysteroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
: Conscious patient satisfaction, hysteroscopic women, lack of nitroglycerin sensitivity, without cardiovascular disease lack of existence of severe bleeding, as well as unstable status
Exclusion criteria:
Systolic blood pressure less than ‌100 mm Hg, intravascular volume reduction, valvular heart disease, severe bleeding, multiparous (NVD 2 ≥ Gravid,) impossibility of using nitroglycerin based on anesthesiologist's sensitivity to any food preservative) Use of hypertension or cardiac drugs for cerebral hemorrhage, anemia, glaucoma, hyperthyroidism, heart problems, heart failure, liver and kidney disease, hypotension and dissatisfaction with continuing the company
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 84
More than 1 sample in each individual
Number of samples in each individual: 42
Recipient of Misoprostol and Nitroglycerin Recipient Group
Randomization (investigator's opinion)
Randomized
Randomization description
randomization/In this study, with a sample size of 84 individuals, 42 balls for the misoprostol intervention group and 42 balls for the nitroglycerin group were placed in a lottery container and then the balls were randomly removed from the container without replacement and the sequence created was recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessors and data analysts will not have information on how to assign groups to patients in groups A and B. We divide the outcome assessor and the patient data analyzer into A and. B know and do not know the nature of groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
No344, block7, 2nd phase, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Approval date
2022-03-26, 1401/01/06
Ethics committee reference number
1401.26

Health conditions studied

1

Description of health condition studied
Cervical ripening before hysteroscopy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervical ripening, bleeding measurment, gravidity, parity, abortion number andside Effects like vomiting, hypotension, dizziness, stomach pain, diarehea, fever
Timepoint
Before hysteroscopy and after using Medicine اand Side Effects after using
Method of measurement
Cervical dilation with measured dilator, bleeding Mount :pad percentage, pain score, weight :kg, gravidity :pregnancy count/parity:living birth delivery, sideeffect like diarehea, flushinv, hypotension, dizziness, headache, fever, nausea اند vomiting

Secondary outcomes

1

Description
Pain score and Mount of bleeding and dilation after hysteroscopy
Timepoint
Before hysteroscopy and after medications
Method of measurement
Pad percentage, pain score، measurment of dilation with measured dilator bouji

Intervention groups

1

Description
Intervention group: nitroglycerin is used in post fornix vaginal for cervical ripening in nuli Gravid women who are candidate for hysteroscopy. In this double-blind clinical trial on 84 women in the age range of 20 to 60 years who were randomly divided into two groups of 42 people in 6-block blocks. Two types of intervention are considered. The first intervention group (42 patients) Pearl nitroglycerin 0.4 mg in the recovery room one to half an hour before the operation up to a maximum of 3 pearls every 5 minutes with the permission of the anesthesiologist will be implanted vaginally in the posterior cervical fornix and For the second intervention group (42 patients), a misoprostol 200 microgram tablet is inserted in the posterior fornix 4 to 6 hours before surgery and the rate of cervical ipening is evaluated with calibrated dilators in both groups. The amount of bleeding and pain before surgery in two Groups are compared
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool akram hospital
Full name of responsible person
Shahla mirgaloo bayat
Street address
No344, entrance 3, block7, phase2, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Phone
+98 21 4465 7764
Email
Melika.ansarin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Research and technology deputy
Street address
No344, entrance 3 block7 phase2, Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Phone
+98 912 075 4021
Email
Melika.ansarin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shahla mirgaloo bayat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No344, entrance 3 block7 phase2 Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Phone
+98 21 4465 7764
Email
Melika.ansarin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla mirgaloo bayat
Position
Associate Processor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No344, entrance 3 block7 phase2 Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Phone
+98 21 4465 7764
Email
Melika.ansarin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahla mirgaloo bayat
Position
Assistant Processor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No344 entrance 3 block7 phase2 Ekbatan town
City
Tehran
Province
Tehran
Postal code
1396813733
Phone
+98 21 4465 7764
Email
Melika.ansarin@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparative effect of nitroglycerin and mesoprostol in cervical ripening
When the data will become available and for how long
8months
To whom data/document is available
Cosultant Processors
Under which criteria data/document could be used
Cervical ripening before hysteroscopy /based on relative information in proposal can be conducted
From where data/document is obtainable
Melika.ansarin@gmail.com
What processes are involved for a request to access data/document
The implementation process of the project in Rasool Akram Hospital is eight months and after that it will be published as an article
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