- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531758
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 (SSC)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye), 06660
- Ankara private hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Skin to skin contact
|
skin to skin contact applied as an immediate and early
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Assessment Tool Scale (IBFAT)
Time Frame: Within 24 hours after cesarean section
|
IBFAT administered to women at the first beastfeeding and postpartum 24th hour to assess breastfeed success.
|
Within 24 hours after cesarean section
|
|
The State-Trait Anxiety Inventory (STAI)
Time Frame: Postpartum 2nd hour
|
Mothers asked to fill out STAI at postpartum 2nd hour for all groups to assess the anxiety levels.
|
Postpartum 2nd hour
|
|
Maternal hemorrhage
Time Frame: Within 24 hours after cesarean section
|
Total Maternal hemorrhage (grams) amounts were measured in all groups at 24 hours postpartum.
|
Within 24 hours after cesarean section
|
|
Body temperature of newborns
Time Frame: Within 24 hours after cesarean section
|
Body temperatures (°C) of newborns were measured with thermometer.
|
Within 24 hours after cesarean section
|
|
Heart rates of newborns
Time Frame: Within 24 hours after cesarean section
|
Heart rates per minute of newborns were measured with pulse oximeter.
|
Within 24 hours after cesarean section
|
|
Peripheral oxygen saturation of newborns
Time Frame: Within 24 hours after cesarean section
|
Peripheral oxygen saturation (%) of newborns were measured with pulse oximeter.
|
Within 24 hours after cesarean section
|
|
Respiratory rate of newborns
Time Frame: Within 24 hours after cesarean section
|
Respiratory rate per minute of newborns were measured.
|
Within 24 hours after cesarean section
|
|
Blood glucose levels of newborns
Time Frame: Postpartum 2nd hour
|
Blood glucose levels (mg/dL) of the newborns were measured with glocometer.
|
Postpartum 2nd hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Newborns' weight loss
Time Frame: Postpartum 24th hour
|
Newborns' weight loss (grams) measured.
|
Postpartum 24th hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayten ŞENTÜRK ERENEL, PhD, Prof. Dr., Gazi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 77082166-302.08.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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