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

Not Applicable

Not yet recruiting

• Conditions: Maternal Health Services; Infant, Newborn; Postnatal Care; Breast Feeding; Maternal-Child Relations; Postpartum Depression (PPD); Mental Health; Lactation; Breast Feeding, Exclusive; Patient Satisfaction and Experience With Integrative Therapies

• Registration Number: NCT07077941
• Lead Sponsor: Medical University of Vienna

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-12
• Last Update Submitted: 2025-07-12
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-10-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 784

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Functioning 1a	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	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	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 Outcome Measures

Name	Time	Method
Effectiveness of breastfeeding	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.
Maternal satisfaction with postnatal care	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.
Detecting symptoms of postnatal depression	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.

Trial Locations

Locations (1)

General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the Department of Gynaecology; 🇦🇹 Vienna, Austria