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review to the effect of physiotherapy after childbirth in primigravid women's incontinence and sexual performance

Protocol summary

Study aim
The aim of this study was determine and comparison the results of phisiotherapy after childbirth in women's incontinence and sexual performance .
Design
In this clinical trial, 114 patients with the inclusion criteria were randomly assigned to two parallel groups of 57 (intervention and control).
Settings and conduct
The study population was primigravid women referred to Alzahra and Beheshti hospitals in Isfahan during the years 1397-98. In the control group, routine recommendations after pregnancy get done. Intervention group is referred to the center of the sedighe Tahere once a week for two months in order to perform phisiotherapy.Then both intervention and control group are reevaluation after 4 months of childbirth with the completion of two questionnaires.
Participants/Inclusion and exclusion criteria
The inclusion criteria for entering the study were Primigravid, over 8 weeks of natural childbirth,the term baby (top 34 weeks) and healthy,no medical and psychological disease, disuse of alcohol and sexual function drug,disuse of forceps and vacum and exclusion criteria were pregnancy during study, the lack of cooperation to continue physiotherapy,addiction,athletic and suffering from uterine prolaps , cyctocele ,rectocele( grade 3,4).
Intervention groups
In the intervention group, primigravid women are referred to the Sedigheh Tahere center 8 weeks after delivery in order to perform pelvic floor exercise Weekly once for two months at this center for 45 minutes. In the control group, routine postpartum advice is given. Patients in this group received no physiotherapy and finally , after2 and 4 months, all patients in the study are required to return to the relevant center and complete the questionnaire again.
Main outcome variables
Sexual function ,incontinency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160521027998N7
Registration date: 2019-03-13, 1397/12/22
Registration timing: registered_while_recruiting

Last update: 2019-03-13, 1397/12/22
Update count: 0
Registration date
2019-03-13, 1397/12/22
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-04-30, 1398/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
review to the effect of physiotherapy after childbirth in primigravid women's incontinence and sexual performance
Public title
Determine the effect of physiotherapy in women's sexual function and incontinence after first child birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primigravid Over 8 weeks of natural childbirth The term baby (top 34 weeks) and healthy No medical and psychological disease Disuse of alcohol and sexual function drug Disuse of forceps and vacum
Exclusion criteria:
pregnancy during study The lack of cooperation to continue physiotherapy Addiction Athletic suffering from uterine prolaps , cyctocele ,rectocele( grade 3,4)
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided in two groups with simple random sampling.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Central Headquarters, Isfahan University of Medical Sciences and Health Services, Hezar Jereb St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.MUI.MED.REC.1397.194

Health conditions studied

1

Description of health condition studied
sexual function disorder
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire

2

Description of health condition studied
urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence

Primary outcomes

1

Description
sexual function disorder
Timepoint
2 and 4 months after delivery
Method of measurement
Based on the female sexual function index questionnaire( FSFI)

2

Description
Fecal and urinary incontinency
Timepoint
2 and 4 months after delivery
Method of measurement
Based on Pelvic Floor Disability Index(PFDI-20) questionnaire

Secondary outcomes

1

Description
The need for physiotherapy 4 month after delivery
Timepoint
4 month after delivery
Method of measurement
Clinical examination and questioning of the patient's symptoms

Intervention groups

1

Description
Intervention group: In this group, primigravid women are referred to the Sedigheh Tahere center 8 weeks after delivery in order to perform pelvic floor exercise Weekly once for two months at this center for 45 minutes. Finally, after2 and 4 months, all patients in the study are required to return to the relevant center and complete the questionnaire again.
Category
Prevention

2

Description
Control group: In the control group, routine postpartum advice is given. Patients in this group received no physiotherapy and finally, after 2 and 4 months, all patients are required to complete the questionnaire.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Maryam Hajihashemi
Street address
Al-Zahra Training Center, Saffeh Blvd - Shahid Keshvari Highway .
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital- Esfahan
Full name of responsible person
Dr.Maryam Hajihashemi
Street address
Motahhari St, Isfahan
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3236 7001
Email
hajhashemy73@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Shaghayegh Haghjooy Javanmard
Street address
Deputy of Research and Technology of Isfahan University of Medical Sciences, Building No. 4, Headquarters, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam al-Sadat Torabipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Saffeh Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 7001
Email
torabipour.maryam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hajihashemi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pelvic Floor disorder
Street address
Alzahra Hospital,Saffeh Ave
City
Isfahan
Province
Isfehan
Postal code
817467-5731
Phone
+98 31 3236 7001
Email
hajhashemy73@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Al-Sadat Torabipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Al-Zahra Hospital, Saffeh Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 7001
Email
torabipour.maryam@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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