The effect of pilates exercise on labor outcom in primiparous women
Design
A_ Clinical trial, Single_ blind, with a control grop, Randomized hexagon block type.
Settings and conduct
Samples are selected from the Women's Clinic of 22 Bahman Hospital. Intervention group starts the exercise from 26 to 28 weeks of pregnancy. Individuals of group exercise Pilates exercise room under the supervision of a trainer during pregnancy 2 session pre week for 8 week and each session for 40 minutes with moderate severity. The control group will receive rotin care during pregnancy and there will be no sports intervention. A researcher_ made questionnaire will be used to measure pregnancy outcomes.
Participants/Inclusion and exclusion criteria
Inclsion criteria: age range from18 to 35 years; nulli parite; 26 to 28 weeks of pregnancy; stutisfaction with participation in the study; exclusion criteria: there are disease such as hypertension; gestational diabetes; heart problems; muscular and skeletal problems; Absense of more than two sessions in sports programs; Dissatisfaction with research.
Intervention groups
Intervention group starts the exercise from 26 to 28 weeks of pregnancy. Individuals of group exercise pilates exercise room under the supervision of a trainer durig pregnancy.the control group will receive rotin care during pregnancy and there will be no sports intervention.
Main outcome variables
Duration of labor, Pilates Exersise Program, type of birh, Birth weight, Birth Apgar, using oxytocin, Episiotomy, severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200126046266N1
Registration date:2020-05-02, 1399/02/13
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
NASIM YOOSEFI GHANDALI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 6333 3457
Email address
yoosefi.n@agums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-11, 1398/11/22
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using Pilates exercise on the outcome of delivery in primiparous women
Public title
The effect of using Pilates exercise on the outcome of delivery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from18 to 35 years
nulli parite
26 to 28 weeks of pregnancy
Stutisfaction with participation in the study
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
110
More than 1 sample in each individual
Number of samples in each individual:
55
55
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is randomized 6 block design. The present study will be conducted as a randomized clinical trial. Pregnant womens will be assigned to intervention and control groups using a randomized block design with 6 block. The research setting will be the 22 Bahman Hospital.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single_ blind in that the evaluators will be kept unaware of the type of treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Uniersity of Medical Scince
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.AJUMS.REC.1398.766
Health conditions studied
1
Description of health condition studied
Pilates exercise and labor outcome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pilates exercise program
Timepoint
The effect of pilates exercise on labor outcome 4to10 weeks after intervention
Method of measurement
اUse a two-part cheek list,the firest section is demographic,information part 2medical information related to research purposes:duration of labor,type of Birth,Birth weight,Birth Apgar,using oxytocin,severity of pain,Episiotomy,Maternal sutisfaction with the delivery experience.
Secondary outcomes
empty
Intervention groups
1
Description
The number of people in the intrvention group will be 55. Intervention group starts the exarcise from 26 to 28 weeks of pregnancy. Individuals of group exercise pilates exercise room under the supervision of a trainer during pregnancy 2 sessions per week for 8 week and each session for 40 minutes with moderate severity. The timing of each session includes: verifiction of posture, warm- up phase( 5_ 8 min), aerobic and toning phase( 25 -30 min), flexibility phase( 5 -10 min) it will help women to relax their muscles and elongate them and the last final phase of returning to a calm state( 5- 10 min) where ralaction techniques will be performed.
Category
Lifestyle
2
Description
The number of people in the control group will be 55. The control group will receve rotin care during pregnancy and there will be no sports intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
22Bahman Masjed Soleiman Hospital
Full name of responsible person
Nasim yoosefi ghand ali
Street address
Number2
City
Masjed Sleiman
Province
Khouzestan
Postal code
6491718131
Phone
+98 61 4323 4971
Email
nsm.yoosefi@gmail.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 Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3092
Email
nsm.yoosefi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nasim Yoosefi ghand ali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 5975
Email
yoosefi.n@gjums.ac.ir
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
Reproductive Health
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 5975
Email
iravani-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasim Yoosefi ghand ali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 5975
Email
yoosefi.n@ajums.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