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Comparative evaluation of the effect of Iyengar and Hata Yoga on the outcomes of labor in pregnant women

Protocol summary

Study aim
Determining the impact of yoga on the outcomes of childbirth
Design
Clinical trial with control group, Hata Yoga intervention group and Yoga practitioner, community-based and pragmatic, randomized Sample size of 72 participants in three groups of Hata and iynegar and control
Settings and conduct
Place of study: Kowsar Hospital The researcher selects and receives written consent from the qualified pregnant mothers (in terms of entry criteria), 72 pregnant women will be selected by available method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having informed consent to participate in the study, 18 to 35 years, first pregnancy and single pregnancy, 26-28 weeks Exclusion criteria: complications during pregnancy, yoga or Pilates experience, attend classes, Tai Chi
Intervention groups
The intervention in this study includes the implementation of two types of yoga programs during pregnancy. . The yoga program for a group is just the style of the hatta yoga, and for a group only the yoga routine and a routine pregnancy care group are being implemented. Participants in the intervention group will begin their first session of pregnancy yoga from 28-26 weeks of gestation, and will hold two sessions for up to 75 minutes each week until the 37th week of gestation. The routine pregnancy care group will receive all pregnancies.
Main outcome variables
Outcomes of labor (type of delivery, occurrence of childbirth induction, premature rupture of the water bag, occurrence of preterm labor, occurrence and degree of episiotomy)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180623040197N2
Registration date: 2019-02-11, 1397/11/22
Registration timing: prospective

Last update: 2019-02-11, 1397/11/22
Update count: 0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Leila Dehghankar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 8034
Email address
l.dehghankar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of Iyengar and Hata Yoga on the outcomes of labor in pregnant women
Public title
Comparative evaluation of the effect of Iyengar and Hata Yoga on the outcomes of labor in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study The age group 18 to 35 years Having normal pregnancy according to the written diagnosis of gynecologist First and single-crocheted pregnancy Ability to read and write Having a normal body mass index (between 8/19 and 26) Pregnancy age 26-28 weeks
Exclusion criteria:
Having experience in yoga classes or regular exercise (Pilates, Tai Chi) Having an abnormal fetus or IUGR. Choosing the method of elective cesarean delivery.
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: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Researcher After initiating the sampling and obtaining a written consent from eligible pregnant mothers (in terms of entry criteria), 72 pregnant women will first be selected in an accessible manner, then they will be selected by random allocation method without placement of individuals. Each pregnant mother who qualifies for study will be placed in a triangular ball of blue (Hatha Yoga) of 24, a red ball (Yoga practitioner) of 24, a green ball (control) of 24, and a pregnant mother of an orb On the basis of that orb, the orb enters the hatta yoga group or the yoga or control group.
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 Qazvin university of medical science
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34417431874
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.QUMS.REC.1397.184

Health conditions studied

1

Description of health condition studied
Preeclampsia
ICD-10 code
O15.1
ICD-10 code description
Eclampsia in labor

2

Description of health condition studied
Preterm labor
ICD-10 code
O42.10
ICD-10 code description
Premature rupture of membranes, onset of labor more than 24 hours following rupture, unspecified weeks of gestation

Primary outcomes

1

Description
type of delivery
Timepoint
in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery
Method of measurement
Outcome of delivery Questionnaire

2

Description
Anesthesia
Timepoint
in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery
Method of measurement
Outcome of delivery Questionnaire

3

Description
Occurrence Premature rupture of the water bag
Timepoint
in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery
Method of measurement
Outcome of delivery Questionnaire

4

Description
Occurrence and  Episiotomy degree
Timepoint
in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery
Method of measurement
Outcome of delivery Questionnaire

Secondary outcomes

1

Description
Preterm delivery
Timepoint
in the beginning of the study (before the intervention) and 2 weeks after completion of the delivery
Method of measurement
Outcome of delivery Questionnaire

Intervention groups

1

Description
Intervention group 1: Hata YogaFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions.
Category
Prevention

2

Description
Intervention group 2: yoga iyengarFrom 28 to 32 weeks of gestation, two weekly sessions take part in yoga sessions.
Category
Prevention

3

Description
Control group: Pregnant mother does not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Leila dehghankar
Street address
Qazvin University of Medical Sciences.Bahonar Blvd,Qazvin,
City
Qazvin
Province
Qazvin
Postal code
344143184
Phone
+98 28 3333 8034
Email
dehghan247@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences , Bahonar street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3441343184
Phone
+98 28 3333 6001
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
leili yekefallah
Position
Assistant Professor of Nursing Faculty Qazvin
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin university of medical science, Bahonar, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
yekefallah@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Nursing Faculty Qazvin
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 0283338034
Email
yekefallah@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leila Dehghankar
Position
Instructor of Qazvin Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 28 3333 6001
Email
L.dehghankar@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the impact of yoga on the consequences of childbirth
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Ghazvin University of Medical Sciences Health Centers Yoga Pregnancy Centers
Under which criteria data/document could be used
Through the authoritative university website
From where data/document is obtainable
Ghazvin, Qazvin University of Medical Sciences, Faculty of Nursing and Midwifery
What processes are involved for a request to access data/document
Send message to authors email
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