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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Elâzığ
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Elazig, Turkey, Elâzığ, Турция (Туркие), 23280
- Elazig Fethi Sekin City Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Breastfeeding Self-Efficacy Scale Score
Временное ограничение: 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.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Postpartum Sleep Quality Scale Score
Временное ограничение: 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
Временное ограничение: 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.
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Baseline (within 48 hours postpartum) and six weeks postpartum
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Exclusive Breastfeeding Status
Временное ограничение: 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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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SYO.26.04 (Другой номер гранта/финансирования: Fırat University Scientific Research Projects Coordination Unit)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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