- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06863753
The Effect of Kangaroo Mother Care on Breastfeeding Success in The Early Postpartum Period (Mother Care)
June 1, 2025 updated by: Gülhan VAROL, Mersin University
The Effect of Kangaroo Mother Care on Breastfeeding Success in The Early Postpartum Period: Randomized Controlled Study
The primary aim of this study was to determine the effect of kangaroo mother care on breastfeeding success in the early postpartum period.
The secondary aim was to determine the effect of kangaroo mother care on the vital signs of the mother and the baby.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
From the selected sample, assignments to the intervention and control groups will be made by stratified block randomization method and randomizer.org
website.
Since it is predicted that mothers' previous breastfeeding experiences may affect breastfeeding success, mothers will be stratified in terms of the number of births (first vaginal birth/ two vaginal births).
After stratification, block randomization will be performed and mothers will be assigned to the intervention and control groups with similar characteristics.
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mersi̇n
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Mersin, Mersi̇n, Turkey
- Mersin Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Inclusion criteria for mothers
- Being over 18 years of age
- Agree to participate in the survey (those who signed the Informed Consent Form)
- Having had their first or second normal birth
- Being literate
- Having no communication problems
- Being a singleton pregnancy
- Having a gestational age of 37-42 weeks
- Being open to communication and cooperation
- Having an intact family unit
Inclusion Criteria for Babies:
- Birth weight 2500-4000 gr. between
- Born by normal delivery
- APGAR score of 7 and above at 1 and 5 minutes
- No health problems or congenital anomalies
- Born between 37 and 42 weeks of pregnancy
Exclusion Criteria:
Exclusion Criteria for Mothers:
- Being under 18 years of age
- Do not agree to participate in the study
- Not being able to read or write
- Having more than two babies
- Having breast problems that prevent breastfeeding
- Being born by Caesarean section
- Having a diagnosed mental or psychological disorder
Exclusion Criteria for Babies:
- Weighing less than 2500 grams
- Weighing more than 4000 grams
- Being born by Caesarean section
- APGAR score of less than 7 at 1 and 5 minutes
- Being born with a congenital anomaly
- Born before 37 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kangaroo mother care
The practice will take place in the mother and baby's room.
Mother and baby will be prepared for the practice.
Kangaroo mother care will be provided once, when the service, mother and baby are available, and then the practice will be performed.
For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin.
Subsequently, the newborn's head will be turned to the side so that the airway remains open.
The newborn will stay in this position for at least 45 minutes.
|
Kangaroo mother care will be practiced once, when the service, mother and baby are available, and then the training will be given.
For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin.
Subsequently, the newborn's head will be turned to the side so that the airway remains open.
The newborn will stay in this position for at least 45 minutes.
|
|
No Intervention: Control
No intervention will be made to the control grup, only the data will be collected at the same time as the study group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH Breastfeeding and Diagnostic Scale mean scores
Time Frame: Baseline and 60th minute
|
This measurement tool consists of five items. The name of the diagnostic tool, LATCH, is formed from the first letters of these five criteria in English.
|
Baseline and 60th minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vital signs of babies
Time Frame: Baseline and 60th minute
|
Body temperature
|
Baseline and 60th minute
|
|
Vital signs of mothers
Time Frame: Baseline and 60th minute
|
Body temperature
|
Baseline and 60th minute
|
|
Vital signs of babies
Time Frame: Baseline and 60th minute
|
Respiratory rate
|
Baseline and 60th minute
|
|
Vital signs of babies
Time Frame: Baseline and 60th minute
|
Oxygen saturation
|
Baseline and 60th minute
|
|
Vital signs of babies
Time Frame: Baseline and 60th minute
|
Heart rate
|
Baseline and 60th minute
|
|
Vital signs of mothers
Time Frame: Baseline and 60th minute
|
Respiratory rate
|
Baseline and 60th minute
|
|
Vital signs of mothers
Time Frame: Baseline and 60th minute
|
Oxygen saturation
|
Baseline and 60th minute
|
|
Vital signs of mothers
Time Frame: Baseline and 60th minute
|
Heart rate
|
Baseline and 60th minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2025
Primary Completion (Actual)
May 31, 2025
Study Completion (Actual)
May 31, 2025
Study Registration Dates
First Submitted
January 5, 2025
First Submitted That Met QC Criteria
March 4, 2025
First Posted (Actual)
March 7, 2025
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
June 1, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- MEU-HEM-GV-220
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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