NCT07523932

Brief Summary

This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section. Participants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care. Data will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools. The study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.

Trial Health

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Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress12%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 5, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Cesarean SectionMidwife-Led InterventionDigital Follow-UpBreastfeeding Self-EfficacySocial SupportPostpartum Care

Outcome Measures

Primary Outcomes (3)

  • Postpartum Depression

    Postpartum depression will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report scale with total scores ranging from 0 to 30. Higher scores will indicate more severe depressive symptoms.

    Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum

  • Perceived Social Support

    Perceived social support will be measured using the Multidimensional Scale of Perceived Social Support (MSPSS), a 12-item scale with total scores ranging from 12 to 84. Higher scores will indicate greater perceived social support.

    Baseline (first postpartum day), 1 week postpartum, and 4 weeks postpartum

  • Breastfeeding Self-Efficacy

    Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale (BSES), a 33-item scale with total scores ranging from 33 to 165. Higher scores will indicate higher breastfeeding self-efficacy.

    Baseline, 1 week, and 4 weeks postpartum

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive a midwife-led face-to-face education session and a 4-week digital follow-up program.

Behavioral: Midwife-Led Digital Follow-Up Program

Control Group

NO INTERVENTION

Participants will receive routine postpartum care without additional structured support.

Interventions

Participants will receive a structured face-to-face education session on the first postpartum day followed by a 4-week digital follow-up program including weekly educational messages, individualized counseling, and continuous support via mobile communication platforms.

Intervention Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes only women who have undergone cesarean section in the postpartum period.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged between 18 and 45 years
  • Women who have undergone cesarean section
  • Within the first 24 hours postpartum
  • Able to communicate in Turkish
  • Having a healthy singleton newborn
  • Willing to participate and provide informed consent

You may not qualify if:

  • History of psychiatric disorders
  • Presence of severe maternal complications
  • Newborn requiring intensive care unit admission
  • Women with communication difficulties
  • Participation in another intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University

Giresun, Giresun, 28200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, PostpartumBreast Feeding

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersFeeding BehaviorBehavior

Central Study Contacts

Emel Güçlü Cihan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention, blinding of participants and care providers will not be possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group receiving a midwife-led digital follow-up program or a control group receiving routine postpartum care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations