NCT07474402

Brief Summary

This study tests a breastfeeding support program for mothers who give birth by cesarean section. The purpose of the study is to see whether the program helps mothers feel more confident about breastfeeding and improves mother-baby bonding.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress41%
Feb 2026Nov 2026

Study Start

First participant enrolled

February 20, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 11, 2026

Last Update Submit

March 21, 2026

Conditions

Keywords

Cesarean SectionBreastfeeding Self-EfficacyMaternal-Infant BondingBreastfeeding SupportPostpartum Period

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale

    Number of Participants Achieving Increased Scores in Breastfeeding Self-Efficacy (14-70, higher = better), LATCH (0-10, higher = better), and Mother-Infant Bonding (19-76, higher = stronger) at 4 Weeks After a Multicomponent Breastfeeding Support Program Following Cesarean Section.

    Baseline (48 hours postpartum)

Secondary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale Mother-Infant Bonding Scale LATCH Breastfeeding Assessment Scale

    4 weeks postpartum follow-up

Study Arms (2)

Intervention Group - Breastfeeding Support Program

EXPERIMENTAL

Participants will be randomly assigned to two groups. The intervention group will receive a multi-component breastfeeding support program including breastfeeding education, counseling, practical breastfeeding support, follow-up support, motivational messages for 28 days, individualized counseling according to participants' needs, telephone follow-up on day 15, and final evaluation via telephone at the end of the month. Participants will also receive a gift package containing a breastfeeding apron with a QR code providing access to a breastfeeding education video, aiming to increase breastfeeding confidence and promote breastfeeding behavior.

Behavioral: Breastfeeding Support Program

Control Group - Routine Postpartum Care

NO INTERVENTION

Control Group - Routine Postpartum Care: Participants in the control group will receive routine postpartum care provided by the hospital. No additional breastfeeding support intervention will be applied to this group.

Interventions

In my thesis, the multi-component breastfeeding support program was applied to address a gap in the literature. Altay and Sarıalioğlu (2024, Breastfeeding Medicine, 19(12):947-956) showed that baby soothing training for primiparous mothers significantly improved maternal role perception, attachment, and breastfeeding self-efficacy (p\<0.001). However, experimental studies simultaneously evaluating breastfeeding education, psychosocial support, video, message, telephone follow-ups, and individualized counseling are limited. Therefore, my study provides strong causal evidence using an experimental design. The sample size (n=100) is larger than many existing studies, and the study uniquely combines three measures: self-efficacy, bonding, and LATCH.

Intervention Group - Breastfeeding Support Program

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly primiparous women who have undergone cesarean section delivery will be included in the study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Primiparous mothers who have completed pregnancy
  • Mothers who delivered by cesarean section (C/S)
  • Mothers in the early postpartum period
  • Mothers aged 18 years and older
  • Mothers who are exclusively breastfeeding
  • Mothers with healthy and stable infants
  • Mothers with no medical conditions that may interfere with breastfeeding
  • Mothers who can read and understand Turkish and complete the data forms

You may not qualify if:

  • Mothers who experienced postpartum complications
  • Infants with severe health problems, congenital anomalies, or requiring intensive care
  • Infants hospitalized in neonatal intensive care unit
  • Mothers with medical or psychiatric conditions that prevent breastfeeding
  • Mothers with multiple pregnancies (twins, triplets, etc.)
  • Mothers who cannot attend follow-up visits during the study
  • Mothers without mobile phones
  • Mothers who received breastfeeding education during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University Hospital

Sivas, Merkez, 58030, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Uzunkaya-Oztoprak P, Koc G, Ozyuncu O. The effect of Kinesio Taping on acute pain, breastfeeding behavior and comfort level in women with cesarean section: A randomized controlled trial. Niger J Clin Pract. 2023 Aug;26(8):1075-1084. doi: 10.4103/njcp.njcp_459_22.

Central Study Contacts

shabnam Behnam Makouei, Master's Student

CONTACT

Prof. Dr. Nilüfer Tuğut, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a pretest-posttest randomized experimental study with parallel groups. Participants are randomly assigned either to the intervention group, which receives a multi-component breastfeeding support program, or to the control group, which receives routine postpartum care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Master's Student

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The study protocol, statistical analysis plan, and SPSS datasets may be shared upon reasonable request while ensuring the protection of participant confidentiality and personal identifying information.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be collected from February 20, 2026, to August 30, 2026. Individual participant data and supporting documents will be available after publication of the study results for 5 years.
Access Criteria
Access to individual participant data and supporting documents will be available to qualified researchers, subject to approval of a data access request. Researchers may access de-identified datasets for scientific purposes after providing a research proposal and agreeing to data sharing and confidentiality conditions.
More information

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