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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05817773
Other study ID # AtaturkU MNailoglu0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date September 15, 2022

Study information

Verified date June 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After cesarean section, mothers who are not mobile and cannot take a suitable position to breastfeed their baby, with the designed breastfeeding cradle, the baby approaches the mother's breast and by taking the appropriate position, effective and easy breastfeeding is ensured.


Description:

Breastfeeding is considered the most appropriate feeding method because it has many benefits for mother and baby. The benefit of breast milk, which is the most beneficial and unique feeding method for the healthy growth and development of babies biologically, psychologically and emotionally, is indisputable. There is no doubt that breast milk is one of the greatest life savers and that breast milk is a miracle. Breastfeeding within the first half hour after birth is one of the Baby-Friendly Hospital criteria, a program of the World Health Organization (WHO) and the United Nations International Children's Emergency Fund (UNICEF). The baby's active period after birth is the first half hour. In this process, breastfeeding affects the success of breastfeeding and the duration of breastfeeding positively. Failure to start breastfeeding in the early postpartum period and the lack of a successful breastfeeding process can have important consequences for the health of the mother and baby in the short and long term. WHO states that breastfeeding in the first half-hour period after birth reduces the risk of death and disease in infants, and then increases breastfeeding rates. International and national organizations have stated that breastfeeding of mothers in the first half-hour period after birth increases the probability of survival of babies, skin-to-skin contact is achieved earlier, increases milk production, including colostrum, and increases uterine involution. There has been a significant increase in cesarean section rates in our country as well as in the world in recent years. According to Turkey Demographic Health Survey (TNSA) 2018 data, cesarean deliveries account for 52% of all deliveries in Turkey. Mothers with cesarean section experience more problems with breastfeeding compared to mothers who gave birth normally. Some of the most important problems with breastfeeding after cesarean section are that mothers have difficulty breastfeeding without the help of someone due to the limitation of movement after cesarean section. Another problem experienced in the early postpartum period after cesarean section is that mothers may not want to breastfeed their babies because of the concern that the baby will experience pain after the baby's contact instead of the cesarean section incision while breastfeeding. Expecting the mother to be mobile for the first breastfeeding negatively affects breastfeeding self-efficacy. The need for support is higher in cesarean deliveries than in normal births. For this, there must be sufficient midwives who can be sufficient here. It is thought that the most important factor in the failure of breastfeeding after cesarean section is the wrong breastfeeding position. In order for breastfeeding to be easier and more comfortable, the tools produced to support breastfeeding should be useful, easy and effective in breastfeeding. Tools used in breastfeeding self-efficacy; breastfeeding support system, breastfeeding pillow, breastfeeding apron and breastfeeding chair.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date September 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 18- 35 years old, Primipar, At least primary school graduate, No high-risk pregnancy Absence of any complications in the birth and postpartum period in the newborn and himself. Exclusion Criteria: Those who have any contraindication for breastfeeding Having a baby under 3000 g, Mothers whose baby was not with them due to any health reasons were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
breastfeeding cradle
Mothers with postop mobile cesarean section should be breastfed with a nursing cradle for 30 minutes every 2-3 hours, even if the baby does not cry, until after mobilization (for 6 hours after coming to the service) every time the baby cries.

Locations

Country Name City State
Turkey Atatürk University Erzurum Erzurum/Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of breastfeeding cradle on breastfeeding self-efficacy breastfeeding cradle is effective on breastfeeding self-efficacy seven months
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