The effect of yoga in pregnancy on birth outcomes in nulliparous women referred to Niknafs hospital in Rafsanjan
Design
Clinical trial with control group without any blinding
Settings and conduct
In the intervention group during the 26-36th week of pregnancy, a of Yoga for 60 minutes per week prepared by a skilled trainer providing a training booklet and DVD, including the basics of yoga, the benefits of each The movements. The intervention group is requested to do yoga exercises three times a week and 20 minutes at home and continue until 37 weeks gestation. The researcher will call the participants twice a week to get notified about doing yoga at home.
Participants/Inclusion and exclusion criteria
Inclusion criteria: signing written consent form; choice Niknafs hospital as the place of birth; nulliparous women; age at least 18 years old; gestational age 26 weeks; single fetus; lack of known medical condition or obstetrical complications; unwillingness to selective cesarean section; no history of yoga or other exercises such as Pilates; abnormal fetal or intrauterine growth restriction confirmed by ultrasound; BMI range: 18.5 - 29.5.
Exclusion criteria: make a high-risk condition at any time during the course of the pregnancy (37 to 26 weeks); attend yoga classes less than five sessions; do yoga less than 20 minutes a week at home; attend a childbirth class; use of spinal anesthesia and pethidine.
Intervention groups
Nulliparous pregnant women who do yoga exercise during pregnancy
Main outcome variables
Duration of the first and second stage of labor; neonate Apgar scores; average labor pain score in dilatation (5-4 cm) and two hours after the first measurement based on the VAS; the amount of anxiety at the entrance to labor room; grade three and four of perineal tear; birth weight of the baby; gestational age on delivery day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181219042051N1
Registration date:2019-05-15, 1398/02/25
Registration timing:registered_while_recruiting
Last update:2019-05-15, 1398/02/25
Update count:0
Registration date
2019-05-15, 1398/02/25
Registrant information
Name
Zohreh Ghorashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
zghorashi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of yoga in pregnancy on some delivery outcome in primiparous women referring to Rafsanjan Niknafs Maternity
Public title
Investigating the effect of yoga in pregnancy on delivery outcome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and signing written consent form
Choice Niknafs hospital as the place of birth
Nulliparous women
Mother's age at least 18 years old
Gestational age 26 weeks based on first trimester ultrasonography or reliable LMP
Single fetus
Lack of known medical condition or obstetrical complications
Unwillingness to selective cesarean section
No history of yoga or other exercises such as Pilates
Abnormal fetal or intrauterine growth restriction confirmed by ultrasound
BMI rang: 18.5 - 29.5
Exclusion criteria:
Make a high-risk condition at any time during the course of the pregnancy (37 to 26 weeks)
Attend yoga classes less than five sessions
Do yoga less than 20 minutes a week at home
Attend a childbirth class
Use of spinal anesthesia and pethidine
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
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
National Ethics Committee for Biomedical Research
Street address
School of Nursing Midwifery, Parastar street
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2018-10-29, 1397/08/07
Ethics committee reference number
IR.RUMS.REC.1397.127
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
labor pain
Timepoint
At the entrance, 4-5 cm dilatation and two hours after first masurment
Method of measurement
VAS
Secondary outcomes
1
Description
Anxiety
Timepoint
At the entrance, 4-5 cm dilatation and two hours after first masurment
Method of measurement
Spielberg State Anxiety Inventory
Intervention groups
1
Description
Intervention group: doing yoga during pregnancy from 26 week of gestation at least 5 sessions and also doing exercises at home.
Category
Prevention
2
Description
Control group: Routine pregnancy care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers
Full name of responsible person
Ellahe mohyadin
Street address
Khalooii street
City
Rafsanjan
Province
Kerman
Postal code
7714659143
Phone
+98 34 3422 3820
Email
Ellahemohyadin.90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vice chancellery for research& technology
Street address
Imam ali bolvard, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Web page address
Grant name
vice chancellery for research& technology of rafsanjan university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Assistant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No6, kargar2, Kargar Ave, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7714816766
Phone
+98 34 3428 9264
Email
zghorashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Parastar street, Rafasanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
zghorashi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Zohreh Ghorashi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Parastar street, Rafasanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
zghorashi@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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