AzTrials
AzTrials

Breast FeedingNCT06502860

Skin-to-Skin Contact With a Sling in Primipar Mothers Who Delivered by Cesarean Section

A study testing skin to skin with sling in people with Breast Feeding and Caesarean Section;Stillbirth, run by Acibadem 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

The first hours after birth are critical for the physiological and psychological adaptation process of the newborn from intrauterine to extrauterine life. The World Health Organization (WHO) recommends skin-to-skin contact as a routine part of care to stabilize the newborn's vital signs and strengthen the… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Feeding, Caesarean Section;Stillbirth
What is being tested?
skin to skin with sling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2024to 11 Aug 2025
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
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Healthy mothers who gave birth by cesarean section
  • Primiparous mothers
  • Healthy newborns

Who cannot join

  • Mothers who gave birth vaginally
  • Newborns using formula milk
  • Mothers with breastfeeding difficulties
  • Preterm newborns
  • Multiple births
  • Mothers and newborns with unstable health conditions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Merve Coşkun

    Ataşehir, Istanbul

Other trials in Turkey (Türkiye)

About this study

The first hours after birth are critical for the physiological and psychological adaptation process of the newborn from intrauterine to extrauterine life. The World Health Organization (WHO) recommends skin-to-skin contact as a routine part of care to stabilize the newborn's vital signs and strengthen the mother-infant bond. However, the rate of skin-to-skin contact in women who give birth by cesarean section is lower compared to vaginal deliveries. Considering the global increase in cesarean birth rates, it is necessary to develop appropriate and practical care methods for mothers and newborns who deliver by cesarean section.

The literature has examined the effects of the duration of skin-to-skin contact on breastfeeding initiation, neonatal hypothermia, and cardiopulmonary stability. However, studies aimed at increasing the duration of skin-to-skin contact are limited. This study compares the effects of standard skin-to-skin contact and skin-to-skin contact using a sling on the duration of skin-to-skin contact, postpartum breastfeeding success, and physiological weight loss of the newborn in primiparous mothers who delivered by cesarean section.

Being tested
skin to skin with sling
Keywords
Skin-to-skin contact, Caesarean section, Breastfeeding success, Newborn physiological weight loss, Sling
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 with slingOther

    In the intervention group, skin-to-skin contact will be facilitated using a specially designed sling. This approach aims to enhance the quality and duration of skin-to-skin contact between the mother and the newborn.

Study groups in NCT06502860
Study groupRoleWhat they receive
Experimental GroupExperimentalThe intervention group will receive skin-to-skin contact facilitated by the use of a sling. Immediately after the cesarean section and stabilization, the newborn will be placed against the mother's bare chest using a specially designed sling. This sling will secure the baby in a safe and comfortable position, allowing for continuous close contact. The duration of skin-to-skin contact will be encouraged to last as long as the mother and baby are comfortable, without any set time limits.
Receives: Other: skin to skin with sling
Control GroupNo interventionThe control group will receive standard skin-to-skin contact without the use of a sling. Immediately after the cesarean section and stabilization, the newborn will be placed directly on the mother's bare chest. This traditional method will involve holding the baby manually to maintain skin-to-skin contact. The duration of skin-to-skin contact will be encouraged to last as long as the mother and baby are comfortable, without any set time limits.

What is being measured

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

  1. Introductory Information Form

    The introductory characteristics of the mother and newborn are documented in forms used by the institution during patient care and in records. These forms are created by the researchers to systematize the information used in this study.

    Measured: Baseline (to both groups before the intervention)

  2. Skin-to-Skin Contact Tracking Form

    This form is created by the researchers to determine the duration of skin-to-skin contact for each participant.

    Measured: To be completed during patient follow-up (postpartum days 0, 1, and 2)

  3. Breastfeeding Assessment Scale (LATCH)

    The scale, developed by Jensen and Wallace in 1993, aims to objectively assess breastfeeding, identify breastfeeding problems, plan education, establish a common language among healthcare professionals, and be used in research (Jensen et al., 1994). The scale was adapted into Turkish by Yenal and Okumuş in 2003 and consists of five assessment steps. It is modeled after the APGAR scoring system and is quick and easy to use. The acronym LATCH stands for the English terms of these assessment steps: "L = Latch on breast," "A = Audible swallowing," "T = Type of nipple," "C = Comfort breast/nipple," "H = Hold." Each item is scored between 0-2 points. The total possible score from the measurement tool is 10. There is no cut-off point for the tool. As the LATCH score increases, the success of breastfeeding is understood to be higher. The scale has a Cronbach alpha value of .95 (Yenal and Okumuş, 2003).

    Measured: To be completed during patient follow-up, once a day (postpartum days 0, 1, and 2)

Timeline

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

  1. First posted16 Jul 2024
  2. Study start15 Sep 2024
  3. Primary completion11 Aug 2025
  4. Study completion11 Aug 2025

Resources

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
Randomized Controlled Experimental Design
Masking
Single blind
Who is masked
Participant
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06502860
Sponsor's protocol ID
2024-5/171
Status last verified
Jan 2026
First submitted
9 Jul 2024
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Takahashi Y, Tamakoshi K, Matsushima M, Kawabe T. Comparison of salivary cortisol, heart rate, and oxygen saturation between early skin-to-skin contact with different initiation and duration times in healthy, full-term infants. Early Hum Dev. 2011 Mar;87(3):151-7. doi: 10.1016/j.earlhumdev.2010.11.012. Epub 2011 Jan 8.

    PubMed 21220191

  • Wigglesworth H, Huddy V, Knowles R, Millings A. Evaluating the impact of sling provision and training upon maternal mental health, wellbeing and parenting: A randomised feasibility trial. PLoS One. 2023 Nov 10;18(11):e0293501. doi: 10.1371/journal.pone.0293501. eCollection 2023.

    PubMed 37948400

  • Kollmann M, Aldrian L, Scheuchenegger A, Mautner E, Herzog SA, Urlesberger B, Raggam RB, Lang U, Obermayer-Pietsch B, Klaritsch P. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study. PLoS One. 2017 Feb 23;12(2):e0168783. doi: 10.1371/journal.pone.0168783. eCollection 2017.

    PubMed 28231274

  • Gouchon S, Gregori D, Picotto A, Patrucco G, Nangeroni M, Di Giulio P. Skin-to-skin contact after cesarean delivery: an experimental study. Nurs Res. 2010 Mar-Apr;59(2):78-84. doi: 10.1097/NNR.0b013e3181d1a8bc.

    PubMed 20179657

Questions about this trial

What is this clinical trial studying?

A study testing skin to skin with sling in people with Breast Feeding and Caesarean Section;Stillbirth, run by Acibadem 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 3 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 30 Jan 2026. 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?

Introductory Information Form (time frame: Baseline (to both groups before the intervention)). The study lists 3 primary outcomes in all. 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 NCT06502860, which also lists 4 linked publications.

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 30 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in