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NCT Number: NCT07077941

Comparing Integrative Midwife-led vs. Fragmented Inpatient Postpartum Care: Impact on 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative Care

Other

Joint care of mother and child by just one healthcare professional

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Effectiveness of breastfeeding

    Time frame: Within 3 days postpartum

    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.

  2. Maternal satisfaction with postnatal care

    Time frame: Approximately 28 days postpartum

    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.

  3. Detecting symptoms of postnatal depression

    Time frame: Approximately 120 days postpartum

    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.

Other outcomes

  1. Breastfeeding process and exclusive breastfeeding rate 7a

    Time frame: Approximately 28 days postpartum

    They are asked whether they are still breastfeeding, whether they are exclusive breastfeeding, when and what they are feeding and what plans they have for the future

  2. Breastfeeding process and exclusive breastfeeding rate 7b

    Time frame: Approximately 120 days postpartum

    They are asked whether they are still breastfeeding, whether they are exclusive breastfeeding, when and what they are feeding and what plans they have for the future

  3. Progression of neonatal jaundice

    Time frame: Within 3 days postpartum

    Neonatal jaundice and the question of whether it needs to be treated

  4. Weight progression

    Time frame: Within 3 days postpartum

    Onset postpartum weight loss below/above 10%

  5. Self-assessment of the state of health of mother and child 11a

    Time frame: Within 3 days postpartum

    One question. On a scale from 1 (very bad) to 5 (very good).

  6. Self-assessment of the state of health of mother and child 11b

    Time frame: Approximately 28 days postpartum

    One question. On a scale from 1 (very bad) to 5 (very good).

  7. Self-assessment of the state of health of mother and child 11c

    Time frame: Approximately 120 days postpartum

    One question. On a scale from 1 (very bad) to 5 (very good)

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Farr, PhD

CONTACT

[email protected]

0043-1-40400 ext. 28220

Vera E. Eschenbach, MSc

CONTACT

[email protected]

+43 69919438971

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Acronym: SMILE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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