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Midwife-Led Home-Based Postpartum Follow-up Program

Effectiveness of a Midwife-Led Home-Based Postpartum Follow-up Program on Breastfeeding Self-Efficacy, Sleep Quality, and Maternal Attachment: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07773207
Enrollment
98
Registered
2026-08-19
Start date
2026-02-12
Completion date
2026-07-28
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, Postpartum Period

Keywords

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

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.

Detailed description

This study was designed as a parallel-group randomized controlled trial conducted among postpartum women at Elazig Fethi Sekin City Hospital in Türkiye. Participants were enrolled during the first 48 hours after birth and randomly allocated in a 1:1 ratio to an intervention group or a control group. Randomization was stratified according to mode of birth, and allocation concealment was maintained using sequentially numbered, opaque, sealed envelopes. Women assigned to the intervention group received a structured, midwife-led postpartum follow-up program in addition to routine care. The program included an individual education session before hospital discharge, a home visit during the second postpartum week, and telephone follow-up during the fourth postpartum week. The pre-discharge session addressed breastfeeding techniques, positioning and attachment, management of common breastfeeding problems, postpartum self-care, sleep hygiene, maternal-infant interaction, and available sources of support. During the home visit, breastfeeding practices and postpartum needs were assessed, individualized counselling was provided, and identified problems were addressed. Telephone follow-up was used to reinforce previous education, assess ongoing concerns, and provide additional counselling when needed. Women assigned to the control group 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. The principal outcome was breastfeeding self-efficacy. Secondary outcomes included postpartum sleep quality and maternal attachment. Outcomes were assessed at baseline during the first 48 hours postpartum and again at six weeks postpartum using validated self-report instruments.

Interventions

BEHAVIORALMidwife-Led Home-Based Postpartum Follow-up Program

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.

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

Sponsors

Serap Öner
Lead SponsorOTHER
Firat University Scientific Research Projects Coordination Unit
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Breastfeeding Self-Efficacy Scale ScoreBaseline (within 48 hours postpartum) and six weeks postpartumBreastfeeding 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.

Secondary

MeasureTime frameDescription
Change in Postpartum Sleep Quality Scale ScoreBaseline (within 48 hours postpartum) and six weeks postpartumPostpartum sleep quality was assessed using the 14-item Postpartum Sleep Quality Scale. The total score ranges from 0 to 56, with higher scores indicating poorer postpartum sleep quality. Change from baseline to six weeks postpartum was evaluated.
Change in Maternal Attachment Inventory ScoreBaseline (within 48 hours postpartum) and six weeks postpartumMaternal attachment was assessed using the 26-item Maternal Attachment Inventory. Each item is scored from 1 to 4, producing a total score ranging from 26 to 104. Higher scores indicate stronger maternal attachment. Change from baseline to six weeks postpartum was evaluated.
Exclusive Breastfeeding StatusSix weeks postpartumExclusive breastfeeding status was assessed based on infant feeding during the preceding 24 hours. Infants receiving only breast milk, with no other food or liquid except medicines, vitamins, or minerals, were classified as exclusively breastfed. The outcome was recorded as yes or no.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026