History
# Registration date Revision Id
2 2022-05-15, 1401/02/25 227382
1 2020-02-08, 1398/11/19 121128
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  • General information

    2019-10-22, 1398/07/30
    2020-03-01, 1398/12/11
    2020-10-21, 1399/07/30
    2021-01-23, 1399/11/04
    empty
    Hi The exact date was sampled corrected. Thanks
    empty
    با سلام و عرض ادب تاریخ دقیق نمونه گیری اصلاح شد. با تشکر

Protocol summary

Study aim
A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 40 people.
Settings and conduct
Semnan Amiralmomenin Hospital. Two hours before the start of the procedure, one group is evening primrose (4 capsules) of mud and the other group is given misoprostol. Then patients will be expected to undergo gynecological surgery.
Participants/Inclusion and exclusion criteria
Pre-menopausal and post-menopausal women undergoing gynecologic surgery. Inclusion criteria: Women 25 to 75 years old; Candidate for gynecology surgery. Exclusion criteria: Heart disease, Liver, Asthma, Seizure; Infection; Bleeding Disorders; Taking anticoagulants.
Intervention groups
Intervention group: According to the protocol, they will receive evening primrose (4 capsules) vaginally 2 hours before surgery. Intervention group: According to the protocol, one tablet of misoprostol will be given intravenously 2 hours before surgery.
Main outcome variables
The rate of cervical opening.

General information

Reason for update
Hi The exact date was sampled corrected. Thanks
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N50
Registration date: 2020-02-08, 1398/11/19
Registration timing: prospective

Last update: 2022-05-24, 1401/03/03
Update count: 1
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-01, 1398/12/11
Expected recruitment end date
2021-01-23, 1399/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
Public title
A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 25 to 75 years old Candidate for gynecology surgery
Exclusion criteria:
Heart disease, Liver, Asthma, Seizure Infection Bleeding Disorders Taking anticoagulants
Age
From 25 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables. Randomized permutation blocks (block 4). Using Excel software to generate random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and clinical caregivers are unaware of the type of medication used in each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.SEMUMS.REC.1398.156

Health conditions studied

1

Description of health condition studied
gynecologic
ICD-10 code
Z01.4
ICD-10 code description
Encounter for gynecological examination

Primary outcomes

1

Description
The rate of cervical opening
Timepoint
Before and after intervention
Method of measurement
Sonography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: According to the protocol, they will receive evening primrose (4 capsules) vaginally 2 hours before surgery.
Category
Treatment - Drugs

2

Description
Intervention group: According to the protocol, one tablet of misoprostol will be given intravenously 2 hours before surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University of Medical Sciences
Full name of responsible person
Nahid Rahbar
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nahid Rahbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nahid Rahbar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Sharaf Shahi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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