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SscSSCNCT07531758

Evaluation of the Effect of Immediate and Early Skin-to-Skin Contact After Cesarean on Maternal and Neonatal Parameters in the First 24 Hours: A Quasi-Experimental Study

A study testing skin to skin contact in people with Ssc and Cesarean Birth, run by Çankırı Karatekin 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
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Trial summary

This study was carried out as a quasi-experimental study to determine the effects of immediate and early skin-to-skin contact (SSC) applied between mother and newborn after cesarean on breastfeeding, anxiety, bleeding and newborn health in the first 24 hours. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Ssc, Cesarean Birth, Neonate
What is being tested?
skin to skin contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Sep 2018to 15 May 2020
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For mothers:
  • Scheduled cesarean section before spontaneous contractions begin
  • Receiving epidural or spinal anesthesia
  • Nulliparous
  • Singleton pregnancy
  • Age 18 and over
Show all 16Show fewer
  • Gestational age 37-42 weeks
  • Literacy
  • No known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
  • No contraindications to breastfeeding (no human T-cell lymphotropic virus (HTLV-1), human immunodeficiency virus (HIV), or active tuberculosis) Speaking Turkish
  • For neonates:
  • Birth weight 2500-4000 gr.
  • Being between 7 and 5 minutes old
  • Having an APGAR score of 7 or higher at 1 and 5 minutes
  • Not having any health problems or congenital anomalies
  • Not having conditions that prevent sucking, such as frenulum (tongue tie) or palate problems

Who cannot join

  • Mothers whose general condition and vital signs deteriorate during skin-to-skin contact
  • Neonates who experience respiratory and circulatory problems during skin-to-skin contact
  • Neonates admitted to intensive care within the first 24 hours
  • Mothers who do not accumulate pads or diapers

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara private hospital

    Ankara, 06660

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Immediate and Early Skin-to-Skin Contact After Cesarean on Maternal and Neonatal Parameters in the First 24 Hours: A Quasi-Experimental Study Design

This study was carried out as a quasi-experimental study to determine the effects of immediate and early skin-to-skin contact (SSC) applied between mother and newborn after cesarean on breastfeeding, anxiety, bleeding and newborn health in the first 24 hours. The application of the study carried out in the cesarean operating room and gynecology services of a private hospital. The required institutional permission and ethics committee approval was received. The sample consisted of 92 mother-infant couples totally, 30 of whom selected to immediate skin-to-skin contact (ISSC), 29 of whom selected to early skin-to-skin contact (ESSC), 33 of whom selected to the control group. The data was collected using Prenatal and postnatal data collection form, Breastfeeding Assessment Tool Scale (IBFAT), The State-Trait Anxiety Inventory and Maternal and newborn follow-up chart for the first 24 hours postpartum. In ISSC group, skin contact was applied within the first 5 minutes after cesarean, and applied to the ESSC group within the first hour after cesarean, and skin contact lasted 40 minutes. The data stored in the SPSS 24 program. In the analysis of the data, Independent Sample-t test, ANOVA test, Paired Sample-t test, Mann-Whitney U test, Kruskal-Wallis H test, Wilcoxon test, Bonferroni correction, Pearson and Spearman correlation coefficient and χ2 test used.

Read the detailed description

Purpose and type of study This research is a quasi-experimental study conducted to examine the effects of immediate and early skin-to-skin contact between mother and newborn after cesarean section on the mother's breastfeeding, anxiety, bleeding, and newborn health in the first 24 hours.

Universe and sample The study was conducted in the postpartum clinics and cesarean section operating room of a private hospital in Ankara. The study was carried out between September 2018 and November 2019 after obtaining the necessary written permissions. To determine the sample number for the study, a pilot study was performed with a total of 15 mother-infant pairs, with 5 pairs in each group. As a result of the pilot study, using the G*Power 3.0.10 program with 80% power, 5% error and the determined 0.15 effect size, at least 87 mother-infant pairs were found to be sufficient for the total study sample size (n1:29; n2:29; n3:29). The sample for the study included a total number of 92 mother-infant pairs with 30 in the ISSC group, 29 in the ESSC group and 33 in the control group. Considering possible losses, the sample included 5% more mother-infant pairs than the lower limit of the sample number.

Women who presented for cesarean section and met the sampling criteria were identified. After being informed of the study's purpose and importance, they agreed to participate. Assignment of women to groups was done using sealed envelopes. For this purpose, one envelope contained a slip of paper labeled "immediate skin-to-skin contact group," another "early skin-to-skin contact group," and a third "control group." Participants were asked to draw a slip of paper from a single envelope to determine their study group. Based on the results, participants were assigned to the immediate skin-to-skin contact group, the early skin-to-skin contact group, and the control group. The study sample consisted of 92 mother-baby pairs in total: 30 in the early skin-to-skin contact group, 29 in the late skin-to-skin contact group, and 33 in the control group. A total of 247 cases were interviewed during the study. A total of 155 cases were lost due to reasons such as the cases not meeting the study criteria (n:98), not volunteering to participate in the study (n:34), the newborn going to the intensive care unit (n:5), the newborn being placed in a post-natal hood (a transparent box in which the entire head of the newborn is placed, most commonly used in neonatal oxygen therapy) (n:10), the mother having nausea, vomiting and pain (n:6), and the mothers forgetting to collect the sanitary pads (n:2).

Inclusion and Exclusion Criteria for the Study

Inclusion criteria for mothers:

  • Scheduled cesarean section before spontaneous contractions begin
  • Receiving epidural or spinal anesthesia
  • Nulliparous
  • Singleton pregnancy
  • Age 18 and over
  • Gestational age 37-42 weeks
  • Literacy
  • No known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
  • No contraindications to breastfeeding (no human T-cell lymphotropic virus (HTLV-1), human immunodeficiency virus (HIV), or active tuberculosis)
  • Speaking Turkish

Inclusion criteria for infants:

  • Birth weight 2500-4000 g
  • Having an APGAR score of 7 or higher at 1 and 5 minutes
  • Not having any health problems or congenital anomalies
  • Not having conditions that prevent sucking, such as frenulum (tongue tie) or palate problems

Excluded from the study:

  • Mothers whose general condition and vital signs deteriorate during skin-to-skin contact
  • Infants who experience respiratory and circulatory problems during skin-to-skin contact
  • Infants admitted to intensive care within the first 24 hours
  • Mothers who do not accumulate pads or diapers

Data collection and application process The operating room team where the procedure would be performed was informed in advance about how to perform skin-to-skin contact. This ensured that electrocardiogram electrodes were placed near the mother's shoulders, not her chest, to monitor her while she lay supine during surgery, leaving the chest area unobstructed.

After birth, SSC between mother and baby was performed after assessing the baby's Apgar score, changing the diaper, putting on a hat, and obtaining approval from the neonatologist and the team. Immediate SSC (ISSC) was initiated by the researcher in five minutes after birth and continued for 40 minutes without interruptions. The baby was placed naked on the mother's bare chest, prone (face down) and horizontal (side down), and covered with a pre-warmed green sheet and the baby's blanket. If the baby started sucking during the procedure, it was supported and observed by the researcher. Those in the early SSC (ESSC) group had this contact implemented after mother and neonate arrived in their room in the ward, beginning within the first hour postnatal (mean 51.48±9.81 minutes). Mother-infant pairs included in the control group did not have any SSC implemented as it is not included as routine practice in the ward.

The researcher, stayed with each woman until the end of the first 3 hours after birth. During this time data were collected with the Prenatal and Postnatal Data Collection Forms, Infant Breastfeeding Assessment Tool (IBFAT), Spielberger State Anxiety Inventory (STAI) and the Maternal and Neonatal Monitoring Timeline for Postnatal First 24 hours. The same devices were used by researcher (glucometer, sensitive scales and saturation measurement device) to be able to perform measurements in all groups in a standardized way. As mothers were discharged in the 24th hour postnatal, data was collected for this period.

The data collection form, covering the prenatal and postnatal periods, inquires about the individual characteristics and health status of the mother and baby. It includes variables such as the mother's age, education level, perceived socioeconomic status, whether the pregnancy was planned, and the reason for cesarean delivery. The section concerning the baby includes variables such as gender, gestational age at birth, birth weight, and 1st and 5th minute APGAR scores, body temperature, heart rate, respiratory rate, saturation, sleep, crying, etc. The forms also include items related to breastfeeding in the postnatal period, such as the mother's first contact with the baby, the timing of first contact and initiation of breastfeeding, measurement of the baby's blood glucose level, and whether the baby is given any food other than breast milk.

In Maternal and Neonatal Monitoring Timeline for Postnatal First 24 hours, the family was instructed to mark the designated areas on the form each time the baby nursed or cried within 24 hours. This allowed the researcher to record how many times the baby nursed and cried at the end of the 24-hour period. The mother and baby were also asked to collect the used diapers and pads in a waste bag provided by the researcher. The empty/clean diapers and pads were weighed before use. After 24 hours, the researcher counted and recorded the number of diaper changes, urination, and bowel movements of the baby, and weighed the diapers. The number of pads used by the mother and the pad weight were also recorded.

Data collected in the research were stored for analysis with the Statistical Package for Social Sciences, version 24.0, for Windows software packet. Analysis of data used descriptive statistics like number and percentage, t-test and chi-square test, ANOVA, Mann-Whitney U test, Kruskal Wallis H test, Wilcoxon test and Bonferroni correction. For evaluation of effect size, the Cohen d value was calculated appropriately with the ANOVA and matched group paired sample methods.

Being tested
skin to skin contact
Keywords
Immediate skin-to-skin contact, early skin-to-skin contact, breastfeeding, neonate, anxiety, maternal hemorrhage
Medical subject headings
Breast Feeding, Anxiety Disorders

What participants receive

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

  • skin to skin contactBehavioural

    skin to skin contact applied as an immediate and early

Study groups in NCT07531758
Study groupRoleWhat they receive
Skin to skin contactExperimentalNot described
Receives: Behavioral: skin to skin contact

What is being measured

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

  1. Breastfeeding Assessment Tool Scale (IBFAT)

    IBFAT administered to women at the first beastfeeding and postpartum 24th hour to assess breastfeed success.

    Measured: Within 24 hours after cesarean section

  2. The State-Trait Anxiety Inventory (STAI)

    Mothers asked to fill out STAI at postpartum 2nd hour for all groups to assess the anxiety levels.

    Measured: Postpartum 2nd hour

  3. Maternal hemorrhage

    Total Maternal hemorrhage (grams) amounts were measured in all groups at 24 hours postpartum.

    Measured: Within 24 hours after cesarean section

  4. Body temperature of newborns

    Body temperatures (°C) of newborns were measured with thermometer.

    Measured: Within 24 hours after cesarean section

  5. Heart rates of newborns

    Heart rates per minute of newborns were measured with pulse oximeter.

    Measured: Within 24 hours after cesarean section

  6. Peripheral oxygen saturation of newborns

    Peripheral oxygen saturation (%) of newborns were measured with pulse oximeter.

    Measured: Within 24 hours after cesarean section

  7. Respiratory rate of newborns

    Respiratory rate per minute of newborns were measured.

    Measured: Within 24 hours after cesarean section

  8. Blood glucose levels of newborns

    Blood glucose levels (mg/dL) of the newborns were measured with glocometer.

    Measured: Postpartum 2nd hour

Secondary outcomes (1)
  1. Newborns' weight loss

    Newborns' weight loss (grams) measured.

    Measured: Postpartum 24th hour

Timeline

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

  1. First posted15 Apr 2026
  2. Study start20 Sep 2018
  3. Primary completion16 Nov 2019
  4. Study completion15 May 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531758
Sponsor's protocol ID
77082166-302.08.01
Acronym
SSC
Status last verified
Apr 2026
First submitted
1 Mar 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing skin to skin contact in people with Ssc and Cesarean Birth, run by Çankırı Karatekin 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 16 inclusion and 4 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 15 Apr 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?

Breastfeeding Assessment Tool Scale (IBFAT) (time frame: Within 24 hours after cesarean section). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Apr 2026.

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