Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative care | Other | Joint care of mother and child by just one healthcare professional |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 3 days postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding process and exclusive breastfeeding rate 7a | 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 | Approximately 28 days postpartum |
| Breastfeeding process and exclusive breastfeeding rate 7b |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera E. Eschenbach, MSc | Contact | +43 69919438971 | vera.eschenbach@gmx.at | |
| Alex Farr, PhD | Contact | 0043-1-40400 | 28220 | alex.farr@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Vienna; Department of Obstetrics and Feto-Maternal Medicine Head of the Department of Gynaecology | Vienna | State of Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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 |
| Approximately 120 days postpartum |
| Progression of neonatal jaundice | Neonatal jaundice and the question of whether it needs to be treated | Within 3 days postpartum |
| Weight progression | Onset postpartum weight loss below/above 10% | Within 3 days postpartum |
| Self-assessment of the state of health of mother and child 11a | One question. On a scale from 1 (very bad) to 5 (very good). | Within 3 days postpartum |
| Self-assessment of the state of health of mother and child 11b | One question. On a scale from 1 (very bad) to 5 (very good). | Approximately 28 days postpartum |
| Self-assessment of the state of health of mother and child 11c | One question. On a scale from 1 (very bad) to 5 (very good) | Approximately 120 days postpartum |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D019052 | Depression, Postpartum |
| D000092862 | Psychological Well-Being |
| D017060 | Patient Satisfaction |
| D007567 | Jaundice, Neonatal |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided