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

NCT07077941 | Not Yet Recruiting

• 1 other identifier: IMC_Model
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Postnatal care; inpatient; maternity competence; satisfaction; integrative care; breastfeeding; maternal behavior

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Approximately 120 days postpartum

Secondary Outcomes (3)

• Effectiveness of breastfeeding

  Within 3 days postpartum

• Maternal satisfaction with postnatal care

  Approximately 28 days postpartum

• Detecting symptoms of postnatal depression

  Approximately 120 days postpartum

Other Outcomes (7)

• Breastfeeding process and exclusive breastfeeding rate 7a

  Approximately 28 days postpartum

• Breastfeeding process and exclusive breastfeeding rate 7b

  Approximately 120 days postpartum

• Progression of neonatal jaundice

  Within 3 days postpartum

Study Arms (2)

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.

Other: Integrative care

Interventions

Integrative care OTHER

Joint care of mother and child by just one healthcare professional

Midwife-led or integrative care model - intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Breast Feeding; Depression, Postpartum; Psychological Well-Being; Patient Satisfaction; Jaundice, Neonatal; Personal Satisfaction

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja A. Stamm, PhD

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

  PRINCIPAL INVESTIGATOR

• Alex Farr, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Vera E. Eschenbach, MSc

CONTACT

+43 69919438971; vera.eschenbach@gmx.at

Alex Farr, PhD

CONTACT

0043-1-40400; alex.farr@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patient Flow Managerin

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)