Objectives: To assess the effect of pelvic floor exercises versus no exercise on the need for episiotomy in nulliparous women.
Design: A randomized clinical trial.
Setting and conduct: The eligible nulliparous women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 20 to 40 years; nulliparous women; 20 weeks of gestational age; singleton pregnancy; educational level of secondary school or higher.
Exclusion criteria: Emergency situation for delivery; abnormal placenta or vasa previa; professional athlete.
Intervention group: Routine care during pregnancy plus pelvic floor exercises including rapid and slow contractive pelvic motion 20 to 30 min 3 times a week for 8 weeks.
Control group: Just routine care during pregnancy.
Primary outcome: The need for episiotomy during delivery based on physical examination.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709159014N185
Registration date:2017-09-22, 1396/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pelvic floor exercises versus no exercise on the need for episiotomy in nulliparous women: a randomized clinical trial
Public title
Effect of pelvic floor exercises versus no exercise on the need for episiotomy in nulliparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 20 to 40 years; nulliparous women; 20 weeks of gestational age; singleton pregnancy; educational level of secondary school or higher.
Exclusion criteria: Emergency situation for delivery; abnormal placenta or vasa previa; professional athlete.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.UMSHA.REC.1396.305
Health conditions studied
1
Description of health condition studied
Episiotomy
ICD-10 code
O90.1
ICD-10 code description
Disruption of perineal obstetric wound
Primary outcomes
1
Description
The need for episiotomy
Timepoint
during delivery
Method of measurement
based on physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during pregnancy plus pelvic floor exercises including rapid and slow contractive pelvic motion 20 to 30 min 3 times a week for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Just routine care during pregnancy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Fetemeh Ghamari Mehran
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Fetemeh Ghamari Mehran
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
alijavad738@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Seyyedh Zahra Masoomi
Position
Specialist in ّFertility Hygiene
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
zahramid2003@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)