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

NCT ID: NCT07077941

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 784 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-12-31

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.

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; Neonatal Jaundice; Maternal Behavior; Body Weight Decreased; Breast Feeding of Healthy Full Term Infants; Lactation Mastitis; Lactation Disorder - Postpartum Condition or Complication; Lactation Disorder With Baby Delivered; Lactation; Insufficient, Partial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nursing care model - control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Midwife-led or integrative care model - intervention group

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.

Group Type: ACTIVE_COMPARATOR

Integrative care

Intervention Type: OTHER

Joint care of mother and child by just one healthcare professional

Interventions

Integrative care

Joint care of mother and child by just one healthcare professional

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Vera Eschenbach

Patient Flow Managerin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanja A. Stamm, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Outcomes Research Center for Medical Data Science Medical University of Vienna

Alex Farr, PhD

Role: STUDY_DIRECTOR

Medical University of Vienna, Dept. of Obstetrics and Gynecology, Division of Feto-Maternal Medicine

Locations

General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the Department of Gynaecology

Vienna, Vienna, Austria

Countries

Austria

Central Contacts

Vera E. Eschenbach, MSc

Role: CONTACT

vera.eschenbach@gmx.at

+43 69919438971

Alex Farr, PhD

Role: CONTACT

alex.farr@meduniwien.ac.at

0043-1-40400 ext. 28220

Facility Contacts

Vera E. Eschenbach, MSc

Role: primary

vera.eschenbach@gmx.at

+43-699-19438971

Alex Farr, PhD

Role: backup

alex.farr@meduniwien.ac.at

043-1-40400 ext. 28220

Other Identifiers

IMC_Model

Identifier Type: -

Identifier Source: org_study_id