NCT06646393

Brief Summary

This study aims to investigate the effect of paternal skin contact on breastfeeding after cesarean section.The research was conducted at Ağrı Training and Research Hospital, Gynecology and Obstetrics Clinic between April 2023 and August 2023.A total of 126 mothers who gave birth by cesarean section, their spouses and newborns, 61 in the skin-to-skin contact group and 65 in the control group, participated in the study. Randomization of the groups participating in the study was done by simple random method using the website www.random.org.The socio-demographic characteristics introduction form, the questionnaire regarding skin-to-skin contact and breastfeeding process, and the LATCH Breastfeeding and Diagnostic Measurement Tool were used to collect research data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

October 14, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

skin to skin contactpaternalbreastfeedingcesarean section

Outcome Measures

Primary Outcomes (1)

  • LATCH breastfeeding diagnostic scale

    by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.

    after skin contact and before discharge

Study Arms (2)

Paternal skin to skin contact group

EXPERIMENTAL

Father-baby skin-to-skin contact was applied within the first hour immediately after the cesarean delivery. During the Father-Baby Skin-to-Skin Contact stage, the newborns were laid face down on their father's bare chest and covered with a blanket.

Other: Skin to skin contact

Control group

NO INTERVENTION

Routine care was given to the control group. After the mothers' procedures were completed, the breastfeeding process was started.

Interventions

Father-baby skin-to-skin contact was applied within the first hour immediately after the cesarean delivery. During the Father-Baby Skin-to-Skin Contact stage, the newborns were laid face down on their father's bare chest and covered with a blanket.

Paternal skin to skin contact group

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Caesarean section
  • single and live birth
  • giving birth between 38-40 weeks
  • not having a mental or physical barrier to breastfeeding,
  • not having a need for neonatal intensive care in the baby,
  • not having a condition that prevents breastfeeding in the baby,
  • not having a condition that prevents skin contact with the baby
  • agreeing to participate in the research

You may not qualify if:

  • Having a vaginal birth
  • Having a premature birth
  • Having a mental or physical disability that prevents breastfeeding
  • Having the baby referred to neonatal intensive care
  • Having a condition that prevents breastfeeding
  • Having a condition that prevents skin-to-skin contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agri Ibrahim Cecen University

Ağrı, Merkez, 04200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The skin-to-skin group received skin-to-skin contact from a midwife working in the clinic. The outcome assessor is not aware of the groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Father-baby skin-to-skin contact was applied within the first hour immediately after the cesarean delivery. During the Father-Baby Skin-to-Skin Contact stage, the newborns were laid face down on their father's bare chest and covered with a blanket.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 17, 2024

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 30, 2023

Last Updated

October 17, 2024

Record last verified: 2023-04

Locations