NCT05817773

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

February 23, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

breastfeeding cradlebreastfeeding self-efficacypostpartum

Outcome Measures

Primary Outcomes (1)

  • The effect of breastfeeding cradle on breastfeeding self-efficacy

    breastfeeding cradle is effective on breastfeeding self-efficacy

    seven months

Study Arms (1)

breastfeeding cradle

EXPERIMENTAL

After the control group was given breastfeeding education and the baby was breastfed, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively. The experimental group was given breastfeeding education and the baby was placed in a nursing cradle and the baby was breastfed. Then, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively.

Device: breastfeeding cradle

Interventions

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.

breastfeeding cradle

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimipar puerperant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Unıversıty

Erzurum, Erzurum/Yakutiye, 25000, Turkey (Türkiye)

Location

Study Officials

  • Serap EJDER APAY, prof

    ataturk university midwifery department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Breastfeeding cradle with remote control system is designed for the mother to breastfeed her baby comfortably. The mother can breastfeed her baby in any position without getting out of bed. Thanks to the remote control, it can give the cradle the desired position. She can safely breastfeed her baby in the cradle with seat belt and safety lock. Breastfeeding cradle with massage, music and light system will provide high comfort for mother and baby.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist midwife

Study Record Dates

First Submitted

February 23, 2023

First Posted

April 18, 2023

Study Start

May 15, 2021

Primary Completion

July 15, 2022

Study Completion

September 15, 2022

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

It is not a plan for use of individual participant data (IPD) by other researchers.

Locations