Trials / Not Yet Recruiting

Not Yet RecruitingNCT07077941

Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 784 (estimated)

Sponsor: Medical University of Vienna · Academic / Other
Sex: Female
Age: 18 Years – 50 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Interventions

Type	Name	Description
OTHER	Integrative care	Joint care of mother and child by just one healthcare professional

Timeline

Start date: 2025-10-01
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2025-07-22
Last updated: 2025-07-22

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT07077941. Inclusion in this directory is not an endorsement.