Maternal Health ServicesSMILENCT07077941
Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on Satisfaction and Transition to Motherhood
A study testing Integrative care in people with Maternal Health Services and Infant, Newborn, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Maternal Health Services, Infant, Newborn, Postnatal Care
- What is being tested?
- Integrative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the Department of Gynaecology
Vienna, State of Vienna, 1090
Vera E. Eschenbach, MSc, +43-699-19438971, vera.eschenbach@gmx.at
Alex Farr, PhD, 043-1-40400 ext. 28220, alex.farr@meduniwien.ac.at
About this study
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
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.
Read the 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
- Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding, Maternal-Child Relations, Postpartum Depression (PPD)
- Being tested
- Integrative care
- Keywords
- Postnatal care, inpatient, maternity competence, satisfaction, integrative care, breastfeeding, maternal behavior
- Medical subject headings
- Breast Feeding, Depression, Postpartum, Psychological Well-Being, Patient Satisfaction, Jaundice, Neonatal, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative careOther
Joint care of mother and child by just one healthcare professional
| Study group | Role | What they receive |
|---|---|---|
| Nursing care model - control group | No intervention | 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 | Active comparator | 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. Receives: Other: Integrative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Functioning 1a
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
Measured: within 3 days postpartum
Maternal Functioning 1b
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
Measured: Approximately 28 days postpartum
Maternal Functioning 1c
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
Measured: Approximately 120 days postpartum
Secondary outcomes (3)
Effectiveness of breastfeeding
The Beginning Breastfeeding Survey-Cumulative (BBS-C) has 24 items, that rated on a scale from 1 ( Always) to 5 (Never). A possible total score ranging from 24 to 120. Higher total cumulative scores on the BBS-C indicate greater breastfeeding effectiveness for the mother and the newborn.
Measured: Within 3 days postpartum
Maternal satisfaction with postnatal care
The WOMen's views of Birth Postnatal Satisfaction Questionnaires (WOMBPNSQ) has 36 items, that rated from 1 (strongly agree) to 7 (strongly disagree). The total score ranges from 36 to 252.
Measured: Approximately 28 days postpartum
Detecting symptoms of postnatal depression
The Edinburgh Postnatal Depression Scale (EPDS) was developed as 10 items instrument, that rated on a scale from 0 to 3 by order of statements. The total score of the scale could be from 0 to 30, where the higher score indicates a higher intensity of depression symptoms.
Measured: Approximately 120 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Health ServicesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 784 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vera Eschenbach, Medical University of Vienna
- Investigators
- Tanja A. Stamm, PhD, Principal investigator, Institute for Outcomes Research Center for Medical Data Science Medical University of ViennaAlex Farr, PhD, Study director, Medical University of Vienna, Dept. of Obstetrics and Gynecology, Division of Feto-Maternal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077941
- Sponsor's protocol ID
- IMC_Model
- Acronym
- SMILE
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07077941
- Acronym / sponsor ID
- SMILE / IMC_Model
- Conditions
- Maternal Health Services, Infant, Newborn, Postnatal Care, Breast Feeding, Maternal-Child Relations, Postpartum Depression (PPD)
- Keywords
- Postnatal care, inpatient, maternity competence, satisfaction, integrative care, breastfeeding, maternal behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 784 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing care model - control group | No intervention | –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 | Active comparator | Other: Integrative careIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative careJoint care of mother and child by just one healthcare professional | Other | Midwife-led or integrative care model - intervention group |
Primary outcome
Maternal Functioning 1a
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanja A. Stamm, PhD principal investigator
Institute for Outcomes Research Center for Medical Data Science Medical University of Vienna
Alex Farr, PhD study director
Medical University of Vienna, Dept. of Obstetrics and Gynecology, Division of Feto-Maternal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative care in people with Maternal Health Services and Infant, Newborn, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera E. Eschenbach, MSc (+43 69919438971, vera.eschenbach@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Functioning 1a (time frame: within 3 days postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.