Skin to Skin ContactNCT06646393

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

A study testing Skin to skin contact in people with Skin to Skin Contact and Skin to Skin Contact in Cesarean Deliveries, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, men onlyHealthy volunteers can take part
Conditions the study is for: Skin to Skin Contact, Skin to Skin Contact in Cesarean Deliveries
What is being tested?: Skin to skin contact
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Apr 2023to 30 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Agri Ibrahim Cecen University
Ağrı, Merkez, 04200

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions: Skin to Skin Contact, Skin to Skin Contact in Cesarean Deliveries
Being tested: Skin to skin contact
Keywords: skin to skin contact, paternal, breastfeeding, cesarean section
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skin to skin contactOther
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.

Study groups in NCT06646393
Study group	Role	What they receive
Paternal skin to skin contact group	Experimental	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. Receives: Other: Skin to skin contact
Control group	No intervention	Routine care was given to the control group. After the mothers' procedures were completed, the breastfeeding process was started.

What is being measured

The primary outcome is the main question the study is designed to answer.

LATCH breastfeeding diagnostic scale
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.
Measured: after skin contact and before discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202330 Aug 2023

First posted17 Oct 2024
Study start1 Apr 2023
Primary completion1 Jun 2023
Study completion30 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin to Skin ContactStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06646393
Sponsor's protocol ID: AgriIbrahimCec
Status last verified: Apr 2023
First submitted: 14 Oct 2024
Last updated: 17 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Not yet recruiting
Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
Preterm Infants, Orogastric Feeding
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
RecruitingObservational study
Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.
Pregnancy, Cesarean Delivery

All Skin to Skin Contact trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Paternal Skin-to-Skin Contact on Breastfeeding Process After Cesarean Section:A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06646393
Acronym / sponsor ID: AgriIbrahimCec
Conditions: Skin to Skin Contact, Skin to Skin Contact in Cesarean Deliveries
Keywords: skin to skin contact, paternal, breastfeeding, cesarean section
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Agri Ibrahim Cecen UniversityUniversity, hospital or other
Study start: 1 Apr 2023 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 30 Aug 2023 (actual)
First posted: 17 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Paternal skin to skin contact group	Experimental	Other: Skin to skin contactFather-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.
Control group	No intervention	–Routine care was given to the control group. After the mothers' procedures were completed, the breastfeeding process was started.

Who may qualify

Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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,

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Skin to skin contactFather-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	Paternal skin to skin contact group

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
Individual participant dataSharing planned: Undecided

Related trials for Skin to Skin Contact

Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Not yet recruiting
Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty
Allergic Contact Dermatitis (ACD)
Not yet recruiting
Effects of Different Positions During Skin-to-Skin Contact in Preterm Infants Receiving Orogastric Feeding
Preterm Infants, Orogastric Feeding
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
RecruitingObservational study
Comparison of Non-Invasive Mean Arterial Blood Pressure Measurements at the Arm and Ankle During Elective Cesarean Delivery.
Pregnancy, Cesarean Delivery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Skin to skin contact in people with Skin to Skin Contact and Skin to Skin Contact in Cesarean Deliveries, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LATCH breastfeeding diagnostic scale (time frame: after skin contact and before discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06646393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.