Investigating the effect of omega-3 fatty acid supplements on women's sexual function during pregnancy
Design
Clinical trial with control group, double-blind, randomized
Settings and conduct
This study is performed on pregnant women in Ahvaz who are under the supervision of public health centers, and is a two-way blind study in which researchers and participants are kept blind.
Participants/Inclusion and exclusion criteria
Pregnant women in 16 to 22 weeks of pregnancy, no chronic illness and depression, Gravid one, no psychiatric medication
Intervention groups
In this study, there are two groups of intervention and control. In the control group, pregnant women in the control group have the same conditions as the intervention group, but in the control group, placebo is used.
Main outcome variables
Improving the sexual function of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200415047078N1
Registration date:2020-05-13, 1399/02/24
Registration timing:prospective
Last update:2020-05-13, 1399/02/24
Update count:0
Registration date
2020-05-13, 1399/02/24
Registrant information
Name
Zeinab Khanjari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 7885
Email address
khanjari.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of omega-3 fatty acid supplements on women's sexual function during pregnancy
Public title
"Investigating the effect of omega-3 on the sexual function of pregnant women"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No anxiety
Lack of chronic illness and depression
Have Literacy
Gestational Age Between 16_22 Week
Gravid 1
Exclusion criteria:
Multiparity
Having depression and chronic illness
Lack of literacy and lack of awareness
Depression
First and third trimesters of pregnancy
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are divided into two groups of pairs and individuals using a table of random numbers (manufacturing of placebo and omega 3 capsule will be done by Zahravi Company of Tabriz and placebo will be made of corn oil). Each instance is given an envelope with code (2 or 1) that the researcher and the sample do not know about the contents of the envelopes, so that code 1 is for the samples that are in the pair group and code 2 is for the sample. The ones that are individual are given. Encoding is done by a third party who is unaware of the research.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a two-blind clinical trial study (researcher and patient). And coding is done by a third party who is unaware of the research.
Placebo
Used
Assignment
Parallel
Other design features
In this study, the anxiety disorder agent is controlled by the Wendenberg Questionnaire.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research
Street address
Golestan Blv, Nursing And Midwifery Department
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Approval date
2020-03-01, 1398/12/11
Ethics committee reference number
IR.AJUMS.REC.1398.935
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Percentage of people with improved sexual function
Timepoint
Determining sexual dysfunction at the beginning of the study and improving sexual function at the end of the study
Method of measurement
Sexual Performance Index Questionnaire
2
Description
Sexual Performance Score in the Sexual Performance Index Questionnaire
Timepoint
Measure sexual function at the beginning and end of the study
Method of measurement
Qeistionnaire Fsfi
Secondary outcomes
empty
Intervention groups
1
Description
In this study, there are two groups of control and intervention. Intervention group: Omega 3 supplement made by Zahravi Company of Tabriz with a dose of 300 mg daily and given to pregnant women for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: There are 62 samples in the control group. In the placebo control group, manufactured by Zahravi Company of Tabriz, it is given daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
University-affiliated health care centers
Full name of responsible person
Zeinab Khanjari
Street address
Golestan.blv
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
Zeinabkhanjari2019@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy Of Research And Technology
Street address
Golestan Blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3571 5794
Email
Zeinabkhanjari2019@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Medical Sience Of Ahvaz
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
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Khanjari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan. Blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8333
Email
Zeinabkhanjari2019@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mina iravani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan.Blv
City
Ahvaz
Province
Khouzestan
Postal code
6135539345
Phone
+98 61 3373 8333
Email
Minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Khanjari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan blv
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8333
Email
Zeinabkhanjari2019@yahoo.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
Demographic information of individuals and data before and after the intervention is reported without mentioning the name
When the data will become available and for how long
Access started in 1400
To whom data/document is available
Only researchers in the field of medical universities
Under which criteria data/document could be used
It can only be used in similar research
From where data/document is obtainable
Researcher's personal email
What processes are involved for a request to access data/document
According to the publication of the article and the registration of the information of the responsible author, the applicant will contact the responsible author to receive the data by academic email and the information will be sent after the approval of the academic email.