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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Elâzığ
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Elazig, Turkey, Elâzığ, Turquía (Türkiye), 23280
- Elazig Fethi Sekin City Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Breastfeeding Self-Efficacy Scale Score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Postpartum Sleep Quality Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SYO.26.04 (Otro número de subvención/financiamiento: Fırat University Scientific Research Projects Coordination Unit)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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