Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrative care.
- Who it may be relevant to
- Registry conditions: Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Other Integrative care
Joint care of mother and child by just one healthcare professional
Primary outcome measures
- Maternal Functioning 1a [Time frame: within 3 days postpartum]
- Maternal Functioning 1b [Time frame: Approximately 28 days postpartum]
- Maternal Functioning 1c [Time frame: Approximately 120 days postpartum]
Secondary outcome measures (3)
- Effectiveness of breastfeeding [Time frame: Within 3 days postpartum]
- Maternal satisfaction with postnatal care [Time frame: Approximately 28 days postpartum]
- Detecting symptoms of postnatal depression [Time frame: Approximately 120 days postpartum]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the D — Vienna
Identifiers
NCT: NCT07077941 · IMC_Model