Midwife-Led Home-Based Postpartum Follow-up Program

NCT07773207 | Completed

• 1 other identifier: SYO.26.04
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated whether a structured, midwife-led home-based postpartum follow-up program could improve breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment among postpartum women. A total of 98 women were randomly assigned in a 1:1 ratio to either the intervention group or the control group. In addition to routine postpartum care, women in the intervention group received an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. Women in the control group received routine postpartum care. Breastfeeding self-efficacy, postpartum sleep quality, and maternal attachment were assessed at baseline and at six weeks postpartum.

Conditions

Postpartum Period; Breast Feeding

Keywords

Breastfeeding Self-Efficacy; Postpartum Sleep Quality; Maternal Attachment; Midwifery Care; Home Visits; Postpartum Follow-Up

Outcome Measures

Primary Outcomes (1)

• Change in Breastfeeding Self-Efficacy Scale Score

  Breastfeeding self-efficacy was assessed using the 33-item Breastfeeding Self-Efficacy Scale. Each item is scored from 1 to 5, producing a total score ranging from 33 to 165. Higher scores indicate greater breastfeeding self-efficacy. Change from baseline to six weeks postpartum was evaluated.

  Baseline (within 48 hours postpartum) and six weeks postpartum

Secondary Outcomes (3)

• Change in Postpartum Sleep Quality Scale Score

  Baseline (within 48 hours postpartum) and six weeks postpartum

• Change in Maternal Attachment Inventory Score

  Baseline (within 48 hours postpartum) and six weeks postpartum

• Exclusive Breastfeeding Status

  Six weeks postpartum

Study Arms (2)

Structured Midwife-Led Postpartum Follow-up Program

EXPERIMENTAL

Participants received routine postpartum care plus a structured, midwife-led follow-up program consisting of an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week.

Behavioral: Midwife-Led Home-Based Postpartum Follow-up Program; Behavioral: Routine Postpartum Care

Routine Postpartum Care

ACTIVE COMPARATOR

Participants received the routine postpartum care and discharge education provided by the hospital. They did not receive the structured home visit or telephone follow-up program during the study period.

Behavioral: Routine Postpartum Care

Interventions

Midwife-Led Home-Based Postpartum Follow-up Program BEHAVIORAL

The program included a 15-minute individual education session before hospital discharge, a home visit of approximately 30 minutes during the second postpartum week, and telephone follow-up during the fourth postpartum week. The program addressed breastfeeding technique, positioning and attachment, management of breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and individualized problem-solving.

Structured Midwife-Led Postpartum Follow-up Program

Routine Postpartum Care BEHAVIORAL

Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.

Routine Postpartum Care; Structured Midwife-Led Postpartum Follow-up Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older Delivered a singleton live-born infant at term (37 weeks of gestation or later) Intended to breastfeed Able to communicate in Turkish Provided written informed consent Both the mother and infant were medically stable and eligible for discharge following routine postpartum care

You may not qualify if:

• A maternal or infant medical condition contraindicating breastfeeding A severe maternal or infant complication requiring prolonged hospitalization or intensive care A diagnosed maternal psychiatric disorder that could interfere with participation Inability to participate in the scheduled follow-up procedures

Sponsors & Collaborators

• Serap Öner: lead
• Firat University Scientific Research Projects Coordination Unit: collaborator

Study Sites (1)

Elazig Fethi Sekin City Hospital

Elazig, Turkey, Elâzığ, 23280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and the researcher delivering the intervention were not masked because of the nature of the intervention. The statistician who performed the analyses was blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention group or the control group in a parallel-group design. Randomization was stratified according to mode of birth.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: February 12, 2026
• Primary Completion: July 28, 2026
• Study Completion: July 28, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning after publication of the study results, with no predetermined end date.
• Access Criteria: Researchers who submit a methodologically sound proposal may request access by contacting the corresponding author. Requests will be evaluated in accordance with participant confidentiality and the conditions of the ethics approval.

Locations

TU (1)