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Midwife-Led Home-Based Postpartum Follow-up Program

14. August 2026 aktualisiert von: Serap Öner

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

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

98

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Elâzığ
      • Elazig, Turkey, Elâzığ, Türkei (türkiye), 23280
        • Elazig Fethi Sekin City Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Structured Midwife-Led Postpartum Follow-up Program
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.
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.
Aktiver Komparator: Routine Postpartum Care
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.
Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Breastfeeding Self-Efficacy Scale Score
Zeitfenster: Baseline (within 48 hours postpartum) and six weeks postpartum
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Postpartum Sleep Quality Scale Score
Zeitfenster: Baseline (within 48 hours postpartum) and six weeks postpartum
Postpartum 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.
Baseline (within 48 hours postpartum) and six weeks postpartum
Change in Maternal Attachment Inventory Score
Zeitfenster: Baseline (within 48 hours postpartum) and six weeks postpartum
Maternal 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.
Baseline (within 48 hours postpartum) and six weeks postpartum
Exclusive Breastfeeding Status
Zeitfenster: Six weeks postpartum
Exclusive 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.
Six weeks postpartum

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Februar 2026

Primärer Abschluss (Tatsächlich)

28. Juli 2026

Studienabschluss (Tatsächlich)

28. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

14. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. August 2026

Zuerst gepostet (Tatsächlich)

19. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SYO.26.04 (Andere Zuschuss-/Finanzierungsnummer: Fırat University Scientific Research Projects Coordination Unit)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the findings reported in this article will be available from the corresponding author upon reasonable request. Data will be shared subject to ethical and confidentiality considerations.

IPD-Sharing-Zeitrahmen

Beginning after publication of the study results, with no predetermined end date.

IPD-Sharing-Zugriffskriterien

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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