- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646393
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
126
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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)
April 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
October 14, 2024
First Submitted That Met QC Criteria
October 16, 2024
First Posted (Actual)
October 17, 2024
Study Record Updates
Last Update Posted (Actual)
October 17, 2024
Last Update Submitted That Met QC Criteria
October 16, 2024
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID 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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