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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Elâzığ
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Elazig, Turkey, Elâzığ, Turkije (Türkiye), 23280
- Elazig Fethi Sekin City Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Actieve vergelijker: 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.
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Routine postpartum care and standard discharge education were provided according to the hospital's usual clinical practice.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Breastfeeding Self-Efficacy Scale Score
Tijdsspanne: Baseline (within 48 hours postpartum) and six weeks postpartum
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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.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Postpartum Sleep Quality Scale Score
Tijdsspanne: Baseline (within 48 hours postpartum) and six weeks postpartum
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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.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Change in Maternal Attachment Inventory Score
Tijdsspanne: Baseline (within 48 hours postpartum) and six weeks postpartum
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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.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Exclusive Breastfeeding Status
Tijdsspanne: Six weeks postpartum
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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.
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Six weeks postpartum
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SYO.26.04 (Ander subsidie-/financieringsnummer: Fırat University Scientific Research Projects Coordination Unit)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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