Protocol summary
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Study aim
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A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
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Design
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Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 40 people.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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The rate of cervical opening.
General information
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Reason for update
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Hi
The exact date was sampled corrected.
Thanks
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Acronym
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IRCT registration information
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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
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Registration date
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2020-02-08, 1398/11/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-01, 1398/12/11
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Expected recruitment end date
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2021-01-23, 1399/11/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
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Public title
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A comparative study of misoprostol and evening primrose for cervical ripening before gynecologic procedures
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women 25 to 75 years old
Candidate for gynecology surgery
Exclusion criteria:
Heart disease, Liver, Asthma, Seizure
Infection
Bleeding Disorders
Taking anticoagulants
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Age
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From 25 years old to 75 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 4).
Using Excel software to generate random number tables.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants and clinical caregivers are unaware of the type of medication used in each group.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-22, 1398/07/30
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Ethics committee reference number
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IR.SEMUMS.REC.1398.156
Health conditions studied
1
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Description of health condition studied
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gynecologic
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ICD-10 code
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Z01.4
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ICD-10 code description
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Encounter for gynecological examination
Primary outcomes
1
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Description
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The rate of cervical opening
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Timepoint
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Before and after intervention
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Method of measurement
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Sonography
Intervention groups
1
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Description
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Intervention group: According to the protocol, they will receive evening primrose (4 capsules) vaginally 2 hours before surgery.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: According to the protocol, one tablet of misoprostol will be given intravenously 2 hours before surgery.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available