NCT05697653

Brief Summary

Due to the separation of the mother and the baby after the cesarean section, initiation of breastfeeding by the mother of the newborn in the first hour of life is delayed. The rate of cesarean section in Turkey has increased to 52%, according to the 2019 data of the Center for Disease Control and Prevention, the rate of cesarean section has increased to 31.7% in the world and up to 65% in the USA. It has been reported in the literature that cesarean deliveries are performed with general, spinal and epidural anesthesia types, and the Apgar scores of newborns after cesarean section performed with spinal and epidural anesthesia are high. In this context, the nurse has a key role in initiating and maintaining breastfeeding after early SSC between the mother and the newborn within the first hour following the cesarean section performed with spinal anesthesia. In the literature, there are studies reporting that skin-to-skin contact applied after normal delivery increases the sucking success of newborns, the successful breastfeeding rate, and the rate of exclusive breastfeeding. There are studies examining the effect of early skin-to-skin contact applied after cesarean section on the suckling success of the newborn and only breastfeeding. Breastfeeding self-efficacy refers to a woman's confidence in her ability to breastfeed her baby. It is reported in the literature that skin-to-skin contact and only breastfeeding education have an effect on breastfeeding self-efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

April 4, 2023

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 21, 2022

Last Update Submit

April 2, 2023

Conditions

Keywords

skin-to-skin contactcesareannewbornbreastfeeding self-efficacy

Outcome Measures

Primary Outcomes (2)

  • The effect of skin-to-skin contact on breastfeeding self efficacy of mothers

    "Breastfeeding Self-Efficacy Scale Short Form" was used to determine mothers' breastfeeding self-efficacy. A high score from the scale indicates that the mother's breastfeeding self-efficacy is high.

    through study completion, an average of 1 year

  • The effect of skin-to-skin contact on breastfeeding success of mothers and sucking success of newborns.

    "LATCH Breastfeeding Diagnostic Scale" was used to determine the effect of skin-to-skin contact on breastfeeding success of mothers and breastfeeding success of newborns. A high score from the scale shows that mothers have good breastfeeding success and newborns have good sucking success. The name of the "LATCH Breastfeeding Diagnostic Scale" consists of the English initials of the 5 assessment criteria; \[L (Latch on the breast), A (Audible swallowing), T (Type of the nipple), C (Comfort breast/nipple), H (Hold)\].

    through study completion, an average of 1 year

Study Arms (2)

intervention group (skin-to-skin contact group)

EXPERIMENTAL

skin-to-skin contact: It is the laying of the newborn in the prone position on the mother's bare chest area with only a diaper on.

Behavioral: Skin-to-Skin contact.

control group

NO INTERVENTION

The routine applications of the hospital were applied to the pregnant women in the control group.

Interventions

Skin to skin contact: It is the laying of the newborn in the prone position on the mother's bare chest with only a diaper on.

intervention group (skin-to-skin contact group)

Eligibility Criteria

Age1 Hour - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mothers;
  • Planning of cesarean section with spinal anesthesia
  • Being between the ages of 18- 45
  • Having a singleton pregnancy
  • Gestational week is between 37-40 weeks
  • Absence of any known health problems (diabetes, gestational diabetes, hypertension, preeclampsia, renal failure, cardiac problems, psychiatric disorders, etc.)
  • Agreeing to participate in the study
  • Before the skin-to-skin contact procedure, their general condition and vital signs should be checked to be stable
  • Being a resident of Kütahya
  • Newborns (0-28 days);
  • Gestational age between 37-40 weeks
  • Birth weight between 2500-4500 g
  • minute Apgar Score ≥ 7
  • Absence of any health problems, anomalies or congenital diseases
  • Absence of obstacles to sucking such as frenulum (tongue-tie) or palate problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: intervention group and control group, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 26, 2023

Study Start

November 18, 2019

Primary Completion

March 13, 2020

Study Completion

May 5, 2021

Last Updated

April 4, 2023

Record last verified: 2022-12

Locations