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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 784
- 试验地点
- 2
- 主要终点
- Maternal Functioning 1a
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nursing care model - control group
In a nursing care model, mother and child are cared for separately. The general nurse, who works in the postnatal ward, is responsible for all the mother's personal matters, while the paediatric nurse, who works in the nursery, is responsible for the newborn's affairs. She is the contact person for questions about breastfeeding and helps with newborn care, for example. The daily ward round is routinely carried out by a doctor on the ward. The paediatrician checks the child's state of health in the nursery once or twice during the stay.
Midwife-led or integrative care model - intervention group
In a midwife-led or integrative form of care, mother and child are cared for together by a midwife. This midwife is the contact person for all matters concerning the mother or the newborn. She is there for all personal, physical and other concerns and supports and helps with all questions relating to the baby, be it questions about breastfeeding or other topics such as newborn care. She also regularly checks the health of mother and child and consults a doctor if necessary. A paediatrician routinely visits the mother's room once or twice to check the child's state of health.
干预措施: Integrative care (Other)
结局指标
主要结局
Maternal Functioning 1a
时间窗: within 3 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
Maternal Functioning 1c
时间窗: Approximately 120 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
Maternal Functioning 1b
时间窗: Approximately 28 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
Maternal Functioning 1a
时间窗: within 3 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
Maternal Functioning 1b
时间窗: Approximately 28 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
Maternal Functioning 1c
时间窗: Approximately 120 days postpartum
The Barkin Index of Maternal Functioning is a 20-item self-report measure, that rated on a scale from 0 (Strongly Disagree) to 6 (Strongly Agree). The total score ranges from 0 to 120, with a score of 120 representing perfect functioning
次要结局
- Maternal satisfaction with postnatal care(Approximately 28 days postpartum)
- Detecting symptoms of postnatal depression(Approximately 120 days postpartum)
- Effectiveness of breastfeeding(Within 3 days postpartum)
- Effectiveness of breastfeeding(Within 3 days postpartum)
- Maternal satisfaction with postnatal care(Approximately 28 days postpartum)
- Detecting symptoms of postnatal depression(Approximately 120 days postpartum)
研究者
Vera Eschenbach
Patient Flow Managerin
Medical University of Vienna