The Effect of Paternal Skin-to-Skin Contact on Breastfeeding Process After Cesarean Section

October 16, 2024 updated by: Emine Serap ÇAĞAN, Agri Ibrahim Cecen University

The Effect of Paternal Skin-to-Skin Contact on Breastfeeding Process After Cesarean Section:A Randomized Controlled Trial

This study aims to investigate the effect of paternal skin contact on breastfeeding after cesarean section.The research was conducted at Ağrı Training and Research Hospital, Gynecology and Obstetrics Clinic between April 2023 and August 2023.A total of 126 mothers who gave birth by cesarean section, their spouses and newborns, 61 in the skin-to-skin contact group and 65 in the control group, participated in the study. Randomization of the groups participating in the study was done by simple random method using the website www.random.org.The socio-demographic characteristics introduction form, the questionnaire regarding skin-to-skin contact and breastfeeding process, and the LATCH Breastfeeding and Diagnostic Measurement Tool were used to collect research data.

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

The research was conducted in two groups: skin contact group and control group. This study aims to investigate the effect of paternal skin contact on breastfeeding after cesarean section.The research was conducted at Ağrı Training and Research Hospital, Gynecology and Obstetrics Clinic between April 2023 and August 2023.A total of 126 mothers who gave birth by cesarean section, their spouses and newborns, 61 in the skin-to-skin contact group and 65 in the control group, participated in the study. Randomization of the groups participating in the study was done by simple random method using the website www.random.org.The socio-demographic characteristics introduction form, the questionnaire regarding skin-to-skin contact and breastfeeding process, and the LATCH Breastfeeding and Diagnostic Measurement Tool were used to collect research data.

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.
126

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 Locations

  • Turkey
    • Merkez
      • Agri, Merkez, Turkey, 04200
        • Agri Ibrahim Cecen University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Caesarean section
  • single and live birth
  • giving birth between 38-40 weeks
  • not having a mental or physical barrier to breastfeeding,
  • not having a need for neonatal intensive care in the baby,
  • not having a condition that prevents breastfeeding in the baby,
  • not having a condition that prevents skin contact with the baby
  • agreeing to participate in the research

Exclusion Criteria:

  • Having a vaginal birth
  • Having a premature birth
  • Having a mental or physical disability that prevents breastfeeding
  • Having the baby referred to neonatal intensive care
  • Having a condition that prevents breastfeeding
  • Having a condition that prevents skin-to-skin contact

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: Paternal skin to skin contact group
Father-baby skin-to-skin contact was applied within the first hour immediately after the cesarean delivery. During the Father-Baby Skin-to-Skin Contact stage, the newborns were laid face down on their father's bare chest and covered with a blanket.
Other: Skin to skin contact
Father-baby skin-to-skin contact was applied within the first hour immediately after the cesarean delivery. During the Father-Baby Skin-to-Skin Contact stage, the newborns were laid face down on their father's bare chest and covered with a blanket.
No Intervention: Control group
Routine care was given to the control group. After the mothers' procedures were completed, the breastfeeding process was started.

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 diagnostic scale
Time Frame: after skin contact and before discharge
by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.
after skin contact and before discharge

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.
Agri Ibrahim Cecen 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.
April 1, 2023

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.
June 1, 2023

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.
August 30, 2023

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).
October 14, 2024

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.
October 16, 2024

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.
October 17, 2024

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.
October 17, 2024

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.
October 16, 2024

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.
April 1, 2023

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.
  • AgriIbrahimCec

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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