Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Integrative care.
- Кому может быть актуально
- Состояния в реестре: Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding. Базовые параметры: 18 лет — 50 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Supporting Mothers With Integrative Care by Midwives for Lifelong Empowerment (SMILE): A Randomized Controlled Trial Comparing Midwife-led Integrative and Fragmented Standard Inpatient Postpartum Care Models on Maternal Satisfaction and Transition to Motherhood
Обзор
The goal of this clinical trial is to compare two different forms of postnatal care to find out which is most beneficial for mothers and their children after birth and with which they are most satisfied. One is a nurse-led, seperate model of care and the other is a midwife-led, integrative model of care. Participants are healthy women between the ages of 18 and 50. They gave birth between 36+0 and 42+0 weeks of pregnancy and had a child. The type of birth is not an inclusion or exclusion criteria. Our hypotheses are: i) that maternal satisfaction with care in a midwife-led, integrative care model is higher than in separate maternal and infant care; ii) that a positive postpartum experience leads to earlier and increased maternity competence; iii) that a higher breastfeeding rate at the time of the survey in the fourth month can be achieved through integrative care. Participants will be randomly assigned, after birth of their child, to either the group cared for by a nurse or the group cared for by a midwife.
Подробное описание
A randomised controlled longitudinal study with three data collection points is being conducted on two postnatal wards.
All women who give birth during the study period, meet the inclusion criteria, and provide informed consent are randomised after delivery to one of the two postnatal wards using Randomiser software. Allocation is stratified by parity, induction of labour, and mode of delivery.
In control group, mothers and their newborns receive care separately according to the standard model by registered general nurses (DGKP) and paediatric nurses (DKKP). In intervention group, mothers and their newborns receive care together from midwives and nursing staff within the framework of an integrative care model.
Regardless of the care model, clinical parameters for both mother and child are gathered at discharge according to the medical record. Additionally, demographic data of the mother is recorded. The mothers are also asked to complete the initial part of the WOMBPMSQ, the Barkin Index of Maternal Functioning (BIMF), and the Beginning Breastfeeding Survey-Cumulative (BBS-C) questionnaire.
One month after birth, participants receive a QR code via SMS or email, granting access to the second data collection. At this point, information is collected on current and previous breastfeeding practices, as well as the health status of both mother and child. Additionally, the second part of the WOMBPNSQ and the BIMF are completed once again.
The third and final data collection occurs four months after birth. Participants receive another QR code to access the online survey. Questions focus on past, current, and intended breastfeeding practices, as well as the health status of both mother and child. Furthermore, the BIMF and the Edinburgh Postnatal Depression Scale (EPDS) are completed. The study concludes with an open-ended question.
Following the completion of data collection, the two groups will be compared based on the collected data.
The following validated questionnaires were selected for this project:
* WOMen's views of Birth Postnatal Satisfaction Questionnaire (WOMBPNSQ) (Smith, 2011; Panagopoulou, 2018; Norhayati et al., 2021), * The Beginning Breastfeeding Survey - Cumulative (BBS-C) (Mulder, 2013), * Barkin Index of Maternal Functioning (BIMF) (Barkin et al., 2010), * Edinburgh Postnatal Depression Scale (EPDS) (Bergant et al., 1998). The EPDS and BIMF are already available in validated German translations. The WOMBPNSQ and BBS-C will be translated into German, adapted, and validated as part of this study.
Вмешательства
- Другое Integrative care
Joint care of mother and child by just one healthcare professional
Первичные конечные точки
- Maternal Functioning 1a [Срок оценки: within 3 days postpartum]
- Maternal Functioning 1b [Срок оценки: Approximately 28 days postpartum]
- Maternal Functioning 1c [Срок оценки: Approximately 120 days postpartum]
Вторичные конечные точки (3)
- Effectiveness of breastfeeding [Срок оценки: Within 3 days postpartum]
- Maternal satisfaction with postnatal care [Срок оценки: Approximately 28 days postpartum]
- Detecting symptoms of postnatal depression [Срок оценки: Approximately 120 days postpartum]
Критерии участия
Критерии включения
- Women aged 18 to 50 years at the time of delivery
- Classified as "low-risk" by the obstetric team in the delivery room
- Gestational age at birth between 36+0 and 42+0 weeks
- Singleton birth (only one child born)
- Intent to breastfeed
- Consent to participate in the study
Критерии исключения
- Women younger than 18 or older than 50 at the time of delivery
- Classified as "high-risk" by the obstetric team
- Multiple birth (e.g., twins, triplets)
- No intention or ability to breastfeed the newborn
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Австрия · 1 центр
- General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the D — Vienna
Идентификаторы
NCT: NCT07077941 · IMC_Model