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Investigating the effect of skin-to-skin contact between mother and newborn immediately after birth on maternal, newborn, and infant growth and development up to 2 months

Protocol summary

Study aim
Determining the effect of skin-to-skin contact between mother and newborn immediately after birth on maternal, neonatal and infant development outcomes at 2 months
Design
A clinical trial, with a control group with parallel groups, a blind strain, randomized, on 72 patients and using blocking for randomization
Settings and conduct
Skin-to-skin contact of mother and baby immediately after birth on maternal and newborn outcomes in the intervention group compared to the control in the patients eligible to enter the study, Yasouj and Korsazi Social Security Shahada Hospital in completing the child development questionnaire and data analysis
Participants/Inclusion and exclusion criteria
Entry requirements 1. Mothers referring for vaginal delivery 2. The gestational age is 37 weeks to 42 weeks Non-entry criteria 1. Placement of the baby in a high-risk group (pre-eclampsia, diabetes, small for gestational age)
Intervention groups
In the intervention group, immediately after discharge, the baby is placed on the mother's stomach with the palm of the hand, and skin contact between the mother and the baby is performed for one hour. The baby will be handed over to the mother in the blanket and the mother will be encouraged to start breastfeeding. Variables are measured in both groups
Main outcome variables
The duration of the third stage of labor, the duration of the first breastfeeding, the duration of the first breastfeeding, breastfeeding success, infant jaundice, infant development, weight gain, height, head circumference and continuation of breastfeeding up to two months.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240118060722N1
Registration date: 2024-05-10, 1403/02/21
Registration timing: registered_while_recruiting

Last update: 2024-05-10, 1403/02/21
Update count: 0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Zahra Gholampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 660 6053
Email address
zahra.golampour@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-08, 1403/02/19
Expected recruitment end date
2024-07-09, 1403/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of skin-to-skin contact between mother and newborn immediately after birth on maternal, newborn, and infant growth and development up to 2 months
Public title
Investigating the effect of skin-to-skin contact between mother and newborn immediately after birth on maternal, newborn, and infant growth and development up to 2 months
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with normal pregnancy and hospitalization for vaginal delivery 2. Gestational age 37 full weeks to 42 weeks 3. Gestational age 37 full weeks to 42 weeks . Single pregnancy Not having a history of medical and psychological problems Residence in Yasuj city
Exclusion criteria:
Placement of the baby in the high-risk group (low birth weight, macrosomia, Apgar score lower than 7 in the first and fifth minutes, meconium contamination, congenital anomalies) Birth complications (such as increased blood pressure, decollement, uterine atony, and 3rd and 4th degree perineal tears)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The block method will be used to assign people to the studied groups. The groups are defined as codes A (one-hour skin contact group (intervention)) and B (usual care group (control). Before assigning people to one of the groups, a list of these letters (A, B) is formed in the form of blocks. Each Which of the qualified applicants are asked to randomly select one of the codes created with different sizes (2, 4, 6, and 8) and assign them to one of the groups. Based on this, they will be placed in two intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind, the questionnaire related to the development of the baby is completed by a trained person who did not participate in the intervention process 2.In the stage of statistical analysis, blinding is done by the relevant expert
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Yasouj University of Medical Sciences
Street address
Sahi Park St., next to Imam Sajjad Hospital, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
IR.YUMS.REC.1402.167

Health conditions studied

1

Description of health condition studied
Maternal and neonatal outcomes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The length of the third stage of labor, neonatal jaundice, the weight, height and head circumference of the infant, the development of the infant
Timepoint
The first hour after birth
Method of measurement
The first hour after birth

2

Description
the success of breastfeeding
Timepoint
The first 24 hours after delivery
Method of measurement
During the first 24 hours after delivery, the baby's breastfeeding is checked and scored based on the checklist

3

Description
Baby jaundice
Timepoint
The first week after birth
Method of measurement
Visit by pediatrician and bilirubin measurement if needed

4

Description
Infant growth and development up to two months
Timepoint
Two months after giving birth
Method of measurement
By filling out the ASQ questionnaire

5

Description
Baby's weight
Timepoint
Birth time and then two months
Method of measurement
Using a scale

6

Description
height of the baby
Timepoint
Birth time and then two months
Method of measurement
Using the meter

7

Description
Around the baby's head
Timepoint
Birth time and then two months
Method of measurement
Using the meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Skin-to-skin contact between mother and baby after birth for one hour, in such a way that actions such as vitamin K injection, weighing and other unnecessary things are postponed until after this one hour, and efforts are made to establish a sense of touch between mother and baby. From showing signs of the baby, such as eating the hand or searching the breast, the baby's breastfeeding is helped in the way that the desire is from the baby's side, and after one hour of skin-to-skin contact, other measures such as weight and other things are carried out and the desired variables are checked
Category
Other

2

Description
Control group: Control group: In the control group, the baby is routinely after birth, which is usually immediate skin contact and less than an hour, and after 1-3 minutes, the umbilical cord is cut and the baby is placed under a warmer, and measures such as vitamin K injection, weight, It is done around the head and towards the baby, and after transferring the mother to the postpartum ward, breastfeeding training measures are given to the mother and the desired variables are checked.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yasouj Social Security Anonymous Martyrs Hospital
Full name of responsible person
Zahra Gholampour
Street address
Cascade Road, the beginning of Eram Blvd., Yasouj Social Security Martyrs Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
759783429
Phone
+98 917 660 6053
Fax
Email
zahragh0068@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Research and Technoommitteelogy C of Yasouj University of Medical Sciences
Street address
Yasuj University of Medical Sciences next to Imam Sajjad Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 917 660 6053
Email
zahragh0068@gmail.com
Web page address
http://www.yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Gholampour
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Eram Blvd. of the Unknown Martyrs Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7593783429
Phone
+98 917 660 6053
Email
zahragh0068@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
zahra
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Eram Blvd., Social Security Anonymous Martyrs Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7593783429
Phone
+98 917 660 6053
Email
zahragh0068@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
zahra gholampour
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Eram Blvd., Social Security Anonymous Martyrs Hospital
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7593783429
Phone
+98 917 660 6053
Email
zahragh0068@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
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