This randomized controlled trial aims to determine the effect of a pelvic floor muscle exercise program on female sexual performance during pregnancy and after childbirth. 84 nulliparous women at 17-20 weeks of gestation aged 18-35 years referring to health centres of Sari city-Iran will be recruited and randomized into two treatment and control groups using stratified block randomization with block sizes of 4 and 6 and allocation ratio 1:1. A person not involved in sampling and data collection will put group identification paper into sequentially numbered sealed opaque packs to conceal allocation sequence. The exercises will be done twice a day; 8-12 set of contractions at each time, every set includes a strong contraction with a maximum possible power holding for 6-8 seconds followed by 3 or 4 contractions in shorter period, with a 10-seconds resting after each contraction. The treatment group will get practical and written education about the exercises at the recruitment day. Accuracy of the exercise performance will be checked at different positions at three about 30-minutes meetings held at 22-24, 28-30, 34-36 weeks of gestation. Also, telephone follow-up will be done weekly in the first month and every other week afterwards. The control group will get usual care. Sexual function, pelvic floor muscle strength, and health related and sexual quality of life will be assessed at 28th-30th weeks of gestation and at third month after birth and urinary incontinence at 34th-36th weeks and the third month after delivery by someone not aware of allocation of the people in the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403013706N22
Registration date:2014-04-04, 1393/01/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-04, 1393/01/15
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-10, 1393/01/21
Expected recruitment end date
2014-07-10, 1393/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a pelvic floor muscle exercise program on sexual function of women during pregnancy and after delivery: a randomized controlled trial
Public title
The effect of a pelvic floor muscle exercise program on sexual function of women during pregnancy and after delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Having a record at the health centres, 2. Having middle school or above education, 3. No history of previous delivery, 4. Having a single pregnancy, 5. Aged 18 to 35 years, 6. Gestational age of 17-20 weeks, 7. Permanent marriage and living with husband.
Exclusion criteria: 1. Addiction to drugs and alcohol, 2. History of two or more abortions, 3. Experience of severe emotional stress within the previous three months, 4. Physical or mental diseases affected on sexual function (e.g., depression, mania, limb amputation or paralysis, the phobias, vaginusmus, 5. Taking medicines affected on sexual function (including blood pressure drugs, thiazide diuretics, anti-depressants, anti-histamines, barbiturates, narcotics, Diazepines and amphetamines, cocaine), 6. History of any pregnancy-related complications limited sexual performance according physician advice (e.g., placenta previa, cervical cerclage) 7. Underlying medical diseases (cardiovascular, gastrointestinal, respiratory, epilepsy, blood pressure), 8. Pelvic floor muscle strength of Level one or less (according to the Oxford grading criteria) or hereditary disease affecting connective tissue (such as Marfan syndrome, muscular dystrophy) or maternal abnormalities in the reproductive system, 9. Having over 12 urinary incontinence episodes per day, 10. Addiction or mental or physical problems of husband affecting on couple sexual function
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Only outcome assessor will be blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Tabriz University of Medical Sciences
Street address
Research Deputy, 3rd floor, Centeral building No 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
92203
Health conditions studied
1
Description of health condition studied
Maternal diseases
ICD-10 code
099
ICD-10 code description
Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
sexual function
Timepoint
At baseline, 28-30 weeks of gestation, 3 months after delivery
Method of measurement
FSFI Questionnaire
Secondary outcomes
1
Description
Pelvic floor muscle strength
Timepoint
At baseline, 28-30 weeks gestation, 3 months after delivery
Method of measurement
Oxford grading system
2
Description
Health-related Quality of Life
Timepoint
28-30 weeks of gestation, 3 months after delivery
Method of measurement
Sf-36 questionnaire
3
Description
Quality of sexual life
Timepoint
28-30 weeks of pregnancy
Method of measurement
SQOL-f Questionnaire
4
Description
Urinary Incontinence
Timepoint
36-34 weeks of gestation, 3 months after delivery
Method of measurement
ICIQ-SF questionnaire.
Intervention groups
1
Description
Intervention group: Pelvic floor exercises will be done twice a day; 8-12 set of contractions at each time, every set includes a strong contraction with a maximum possible power holding for 6-8 seconds followed by 3 or 4 contractions in shorter period, with a 10-seconds resting after each contraction. The treatment group will get practical and written education about the exercises at the recruitment day. Accuracy of the exercise performance will be checked at different positions at three about 30-minutes meetings held at 22-24, 28-30, 34-36 weeks of gestation. Also, telephone follow-up will be done weekly in the first month and every other week afterwards.
Category
Prevention
2
Description
Control group will receive regular care and will get education on personal hygiene and care of the newborn at one session at 28- 30 weeks of gestation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health centers in Sari city
Full name of responsible person
Zahra Pourkhiz- MSc student in midwifery
Street address
Sari, Shahband street, Province health center
City
Sari
2
Recruitment center
Name of recruitment center
Clinic 1
Full name of responsible person
Zahra Pourkhiz- MSc student in midwifery
Street address
Amyrmazndrany Street, opposite the mosque Abolfazl
City
Sari
3
Recruitment center
Name of recruitment center
Clinic 2
Full name of responsible person
Zahra Pourkhiz - MSc student in midwifery
Street address
shohda Square, in front of Technical-Professional
City
Sari
4
Recruitment center
Name of recruitment center
Clinic 3 (Resalat)
Full name of responsible person
Zahra Pourkhiz - MSc student in midwifery
Street address
Rahband street, Lane Ghanbari
City
Sari
5
Recruitment center
Name of recruitment center
Clinic 4 (Clinic Adibi martyr)
Full name of responsible person
Zahra Pourkhiz - MSc student in midwifery
Street address
Imam Reza Boulevard, Tajan Bridge
City
Sari
6
Recruitment center
Name of recruitment center
Clinic 6 (Clinic of Red Crescent)
Full name of responsible person
zahra.pourkhiz - MSc student in midwifery
Street address
Saat Square, 18 day street
City
Sari
7
Recruitment center
Name of recruitment center
clinic 7 (Shahid Babaie)
Full name of responsible person
Zahra Pourkhiz - MSc student in midwifery
Street address
Rahband street
City
Sari
8
Recruitment center
Name of recruitment center
Clinic 8
Full name of responsible person
Zahra Pourkhiz - MSc student in midwifery
Street address
Rahband street
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor,Centeral building No 2 , Tabriz University of medical Sciences, Golgasht st., Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Midwifery Department, Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Zahra Pourkhiz
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Kousar Dormitory, South Shariati Ave, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 15 1323 4278
Fax
Email
zahra.pourkhiz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Associate Professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 1477 2699
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Midwifery Department, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh
Position
Associate Professor, PhD in Reproductive Health
Other areas of specialty/work
Street address
Midwifery Department, Faculty of Nursing and Midwifery,South Shariati, Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)