Investigating the effect of the mother's squatting position during labor on the correction of the posterior occiput position of the fetus and the maternal and neonatal outcomes
Determining the effect of squat position of mother during labor on the correction of the posterior occiput position of the fetus and maternal and neonatal outcomes.
Design
A clinical trial with a control group, in parallel, randomized, which was used the rand function of Excel software.
Settings and conduct
In the intervention group, in addition to the routine midwifery care until delivery, alternately during labor, various squat models were performed in 2 to 3 time periods based on the mother's comfort (which is 15 minutes per hour in total). In the control group, they are placed in the routine ward and receive the usual care.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. First pregnant women
2. Gestational age according to the LMP and ultrasound of the first trimester of pregnancy equal to 37 weeks or more.
3. The position of the fetal head has been diagnosed through 2 vaginal examinations with a minimum interval of 2 hours from the posterior occiput.
4. Singleton pregnancy
5. The age range between 18 and 40 years.
6. BMI in the first trimester between 18-30 kg/m2.
7. The mother is at the beginning of the active phase of labor and dilation is 4 cm.
8. Bishop score 4 and more
Exclusion criteria:
1. High-risk pregnancies
2. Premature delivery
3. Need to induce labor with oxytocin
4. Vaginal bleeding
5. Existence of cases where active movement of the mother during labor was prohibited.
6. Amniotic fluid stained with meconium.
Intervention groups
Intervention: doing the squat position during labor
Control: routine care
Main outcome variables
1. Correction of the posterior occiput position of the fetus
2. Maternal and neonatal outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240705062332N1
Registration date:2024-07-17, 1403/04/27
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:0
Registration date
2024-07-17, 1403/04/27
Registrant information
Name
Nila Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4356 7119
Email address
norouzi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-19, 1403/04/29
Expected recruitment end date
2024-12-19, 1403/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of the mother's squatting position during labor on the correction of the posterior occiput position of the fetus and the maternal and neonatal outcomes
Public title
The effect of the squat position on the correction of the posterior occiput position of the fetus and maternal and neonatal outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnant women
Gestational age according to the first day of the last period and ultrasound of the first trimester of pregnancy equal to 37 weeks or more
The position of the fetal head has been diagnosed through 2 vaginal examinations with a minimum interval of 2 hours of the posterior occiput, and when the second vaginal examination confirms the position of the posterior occiput, the posterior occiput should be confirmed by ultrasound
Single pregnancy
The age range of the mother is between 18 and 40 years
Body mass index in the first trimester of pregnancy between 18-30 kg/m2
The mother should be at the beginning of the active phase of labor and in dilatation of 4 cm
Bishop score 4 and more
Exclusion criteria:
High-risk pregnancies
Premature birth
The need to induce labor with oxytocin
Presence of vaginal bleeding
Existence of cases where active movement of the mother during labor is prohibited
Amniotic fluid stained with meconium.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
272
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with computer software and generating random numbers.
The corresponding numbers will be written on the cards and placed in a sealed envelope. In a simple randomization method, a pregnant woman takes an envelope when entering labor and according to the corresponding number, people will be placed in different intervention or control groups.
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 Ahvaz University of Medical Sciences
Street address
Ahvaz, Academic City, Vice-Chancellor for Research and Information Technology, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-06-29, 1403/04/09
Ethics committee reference number
IR.AJUMS.REC.1403.151
Health conditions studied
1
Description of health condition studied
Correction of the posterior occiput position of the fetus
ICD-10 code
P03.1
ICD-10 code description
Newborn (suspected to be) affected by other malpresentation, malposition and disproportion during labor and delivery
2
Description of health condition studied
Maternal and neonatal outcomes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Correction of the posterior occiput position of the fetus
Timepoint
During intervention until delivery
Method of measurement
Vaginal examination
Secondary outcomes
1
Description
Frequency of episiotomy
Timepoint
Immediately after vaginal delivery
Method of measurement
Observation registration checklist
2
Description
Apgar score of the first and fifth minutes of the baby
Timepoint
The first and fifth minutes after childbirth
Method of measurement
Apgar score is obtained from the total scores of five components: heart rate, respiratory rate, muscle tone, irritability and reflexes, skin color of the baby
3
Description
Type of delivery
Timepoint
Immediately after delivery
Method of measurement
Observation registration checklist
4
Description
Frequency of third and fourth degree tears
Timepoint
Immediately after vaginal delivery
Method of measurement
Based on the grading of tears and registration in the observation registration checklist
5
Description
Severity of labor pain
Timepoint
At the peak of uterine contraction
Method of measurement
Visual pain measurement criteria and McGill questionnaire
6
Description
The duration of the active phase of labor
Timepoint
From the beginning of the active phase of the first stage of labor to dilatation of 10 cm
Method of measurement
Based on the minutes and record in the observation registration checklist
7
Description
The duration of the second stage of labor
Timepoint
From the dilatation of 10 cm of the cervix to the complete exit of the fetus
Method of measurement
Based on the minutes and record in the observation registration checklist
Intervention groups
1
Description
Intervention group1: In addition to receiving routine midwifery care, the intervention group is placed in the squat position for 15 minutes per hour alternately based on the mother's request and convenience (15 minutes per hour in total) during the active phase of the first stage until delivery. During rest, the mother will be in desired positions (sitting, walking and in most cases sleeping).
Category
Prevention
2
Description
Control group1: They will be placed in a routine and desired situation and will receive the usual care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Nila Norouzi
Street address
Sina Hospital, Imam Ali Square, 1 Shahid Street, Karoun City, Ayatollah Behbahani Highway
City
Ahvaz
Province
Khouzestan
Postal code
6199117111
Phone
+98 61 9911 7111
Email
sinahospital.ch@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnush Zaker Kish
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 1984
Email
itc@ajums.ac.ir
Web page address
http://behsan.ajums.ac.ir
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
Nila Norouzi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan Blvd., Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8396
Email
Nilanorouzi2878@gmail.com
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
Midwifery
Street address
Ahvaz, Golestan Blvd., Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8396
Email
minairavani2004@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nila Norouzi
Position
Midwifery master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan Blvd., Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 71 4356 7119
Email
Nilanorouzi2878@gmail.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
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