Effect of squat exercise during active childbirth versus control group on maternal and neonatal outcomes of primiparous women: a randomized clinical trial
To assess the effect of squat exercise during active childbirth versus control group on maternal and neonatal outcomes of primiparous women
Design
This is a randomized clinical trial study with a parallel, unblinded control group of 104 samples. Eligible primiparous pregnant women will be randomly assigned to intervention and control groups using drawing cards.
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 104 eligible primiparous women. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 35 years;
Primiparous pregnant woman;
Gestation age 38 to 42 weeks;
Natural childbirth.
Exclusion criteria:
Placenta previa;
Any fetal abnormality;
History of hip surgery;
Uncontrolled preeclampsia or eclampsia;
Fetus more than 4 kg.
Intervention groups
Intervention group:
Routine care during childbirth, in addition to doing squat exercises with half-bent knees and giving the pelvis back and then straightening again 10-15 times in 5-10 seconds for 30 minutes during the active phase
Control group:
Just routine care during childbirth
Main outcome variables
Primary outcome:
The degree of dilatation, the degree of effacement, the duration of uterine contractions, the intensity of uterine contractions, fetal position, newborn's Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N475
Registration date:2023-06-22, 1402/04/01
Registration timing:prospective
Last update:2023-06-22, 1402/04/01
Update count:0
Registration date
2023-06-22, 1402/04/01
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
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of squat exercise during active childbirth versus control group on maternal and neonatal outcomes of primiparous women: a randomized clinical trial
Public title
Effect of squat exercise during active childbirth versus control group on maternal and neonatal outcomes of primiparous women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Primiparous pregnant woman
Gestation age 38 to 42 weeks
Natural childbirth
Exclusion criteria:
Placenta previa
Any fetal abnormality
History of hip surgery
Uncontrolled preeclampsia or eclampsia
Fetus more than 4 kg
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:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention 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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.UMSHA.REC.1402.112
Health conditions studied
1
Description of health condition studied
Outcome of delivery
ICD-10 code
Z37
ICD-10 code description
Outcome of delivery
Primary outcomes
1
Description
The degree of dilatation
Timepoint
During the active phase of labor
Method of measurement
By clinical examination
2
Description
The degree of effacement
Timepoint
During the active phase of labor
Method of measurement
By clinical examination
3
Description
The duration of uterine contractions
Timepoint
During the active phase of labor
Method of measurement
By clinical examination
4
Description
The intensity of uterine contractions
Timepoint
During the active phase of labor
Method of measurement
By clinical examination
5
Description
Fetal position
Timepoint
During the active phase of labor
Method of measurement
By clinical examination
6
Description
Newborn's Apgar score
Timepoint
At 1 and 5 minutes
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during childbirth, in addition to doing squat exercises with half-bent knees and giving the pelvis back and then straightening again 10-15 times in 5-10 seconds for 30 minutes during the active phase
Category
Other
2
Description
Control group: Just routine care during childbirth
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Golsa Sepehri Nejati
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
golsasepehrinejati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mahtab Sattari
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahtabsattari212@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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