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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Mersi̇n
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Kangoroo mother care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

  • L, Latch on the breast;
  • A, Audible swallowing;
  • T, Type of the nipple;
  • C, Comfort breast/nipple of the mother;
  • H, Hold/Help position of the baby. Each item is evaluated between 0-2 points. The total score that can be obtained from the scale is 10, and a high score means high breastfeeding success.
Baseline and 60th minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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