To determine the effect of vaginal oxytocin on sexual dysfunction in lactating women
Design
Clinical trial, with control group, with parallel groups, triple blind, randomized
Settings and conduct
This study will be conducted on 68 lactating women referring to community health centers in Tabriz. Participants will be divided into two groups by randomized blocking method and an assignment ratio of 1:1. The intervention group will receive Oxytocin jel and the control group will receive placebo jel. Both groups will take drug or placebo once a day for 8 weeks.
Participants/Inclusion and exclusion criteria
The participants will be lactating women during 6 weeks and 6 months after delivery who obtain female Sexual Function Index (FSFI) score lower than 26.5 and a depression score of less than 13 based on the Edinburg depression scale at the initial evaluation.
Intervention groups
the intervention group will receive oxytocin jel and the control group will receive placebo jel
Main outcome variables
The main outcome variable include sexual function that will be assessed by female sexual function index before and eight weeks after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N55
Registration date:2020-05-27, 1399/03/07
Registration timing:prospective
Last update:2020-05-27, 1399/03/07
Update count:0
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-29, 1399/03/09
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vaginal oxytocin on sexual function in lactating women: a randomised controlled trial
Public title
The effect of vaginal oxytocin on sexual function in lactating women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lactating women
Passing at least 6 weeks and 6 months after delivery
Female Sexual Function Index (FSFI) score less than 26.5 at the initial evaluation
Having a depression score of less than 13 based on the Edinburg Postpartum Depression Scale
Having active life based on sexual relationship
Exclusion criteria:
Pregnant women
A history of grief and postpartum depression
A history of taking depression and other psychiatric drugs
History of hormone therapy for sexual dysfunction during the past two weeks
A history of chemotherapy or pelvic radiation therapy
Any chronic and uncontrolled illness such as diabetes
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4 and 6 and the allocation ratio of 1:1. A person not involved in the sampling will generate allocation sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-05-14, 1399/02/25
Ethics committee reference number
IR.TBZMED.REC.1399.121
Health conditions studied
1
Description of health condition studied
Sexual dysfunctionse
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
Before and 8 weeks after intervention
Method of measurement
Female Sexual Function Index
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before and 8 weeks after intervention
Method of measurement
Sexual Satisfaction Scale for Women
2
Description
Depression
Timepoint
Before and 8 weeks after intervention
Method of measurement
Edinbuurgh Postnatal Depression Scale
Intervention groups
1
Description
The intervention group will receive oxytocin vaginal jel daily for 8 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive placebo vaginal jel daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers of Tabriz
Full name of responsible person
Arezu Mesbahi
Street address
Nursing and Midwifery faculty, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5178686941
Phone
+98 41 3441 5907
Email
arezumesbahimidwife@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Arezu Mesbahi
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3441 5907
Email
arezumesbahimidwife@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghaforvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghaforvandm@tbzmed.ac.ir
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
Participants data is confidential.
Study Protocol
No - There is not 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
Yes - There is 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
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document