Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway
Study Details
Study Description
Brief Summary
Due to the fetoneonatal pathway it is possible to identify pregnant women with an increased risk of fetal growth restriction or pre-eclampsia in early stages (from 10th week of pregnancy). Women whose pregnancy is considered high-risk receives risk-adapted prenatal treatment as well as certain treatments for their newborn and infant until 1 year of age. The tasks of all involved persons are defined by standard operating procedures (SOP)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
By implementing a preventive feto-neonatal pathway, healthcare for pregnant women with high risk of fetal growth restriction (FGR) or pre-eclampsia will be improved and, therefore the occurence of children's health problems may be prevented.The pathway allows healthcare to be structured, ross-sectoral, inter- and multidisciplinary in consideration of medical and psychosocial imensions. The feto-neonatal pathway transfers scientific findings, which already determine international routine care, in the project region into clinical routine care. The anamnestically increased risk for FGR or pre-eclampsia is validated by ultrasound and the identified high-risk pregnancy is attended risk-adapted from birth until the end of the first year of life of the child.As a result, the mothers' pregnancy-related risks (death, premature delivery, traumatic stress disorders) as well as risks for the child (prematurity and associated problems, childhood growth restriction with the risk of metabolic syndrome, developmental neurological problems) are reduced and the sustainability of the interventions is ensured in the long term through improved health competence of the families. The feto-neonatal pathway shows how highly specialised fetoneonatal care of high-risk pregnancies can be ensured while ensuring primary care in a health region, and offers the possibility of being extended to other indications.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: consecutive fetoneonatal healthcare inclusion criteria: pregnant woman having higher risk of early fetal growth restriction, preeclempsia living in studyregion (east-Saxony or east Thuringia) the fetoneonatal pathway consists of four consecutive parts: (1) early perceiving of pregnant women with higher risks for early fetal growth restrictions via color Doppler sonography, fetal biometry, haemogram check (currently additional screenings) (2) structured care of the high risk women who are pregnant (3) concerted neonatal health care (4) adapted paediatric aftercare, certain dates and responsible persons are scheduled. |
Other: consecutive fetoneonatal healthcare pathway
(1) early perceiving of pregnant women with higher risks for early fetal growth restrictions via color Doppler sonography, fetal biometry, haemogram check (currently additional screenings) (2) structured care of the high risk women who are pregnant (3) concerted neonatal health care (4) adapted paediatric aftercare, certain dates and responsible persons are scheduled.
|
| No Intervention: standard fetoneonatal healthcare inclusion criteria: due to health insurance data by AOK PPLUS & ikk classics propsensityscorematched pregnant women living in west Saxony and Thuringia, being not part of the intervention group receiving standard health care. |
Outcome Measures
Primary Outcome Measures
- Evaluation of patients' safety: maternal pre-eclampsia rate [through study completion, an average of 1 year and 7 months]
self-designed questionnaire, health information
- Evaluation of patients' safety: newborn's birthweight adjusted by gestational age [through study completion, an average of 1 year and 7 months]
self-designed questionnaire, health information
- Evaluation of patients' safety: maternal morbidity [through study completion, an average of 1 year and 7 months]
self-designed questionnaire, health information
- Evaluation of patients' safety: infantil morbidity [through study completion, an average of 1 year and 7 months]
self-designed questionnaire, health information
- Evaluation of patients' safety: Quality of life [through study completion, an average of 1 year and 7 months]
Questionnaire: Quality of Life (Angermayer, Kilin & Matschinger, 2000)
- Evaluation of patients' safety: attachment behavior [through study completion, an average of 1 year and 7 months]
Questionnaire: Postpartum Bonding Questionnaire (Reck et al., 2006)
- Evaluation of patient's access to treatment and satisfaction [through study completion, an average of 1 year and 7 months]
self-designed questionnaire
- claim of the health services [From admission to discharge, study inclusion to one year postpartum)]
based on self-designed questionnaires
- prohibition of employment [From admission to discharge, study inclusion to one year postpartum)]
based on self-designed questionnaires
- duration of unemployability [From admission to discharge, study inclusion to one year postpartum)]
based on self-designed questionnaires
Secondary Outcome Measures
- health economical evaluation [From admission to discharge, study inclusion to one year postpartum]
cost-benefit-analysis of patients' outcome in relation to supply costs based on secondary data provided by Health insurance funds
- evaluation of ungoing processes during the fetoneontal health care pathway: target patients [From admission to discharge, study inclusion to one year postpartum]
based on secondary data provided by Health insurance funds
- evaluation of ungoing processes during the fetoneontal health care pathway: effectiveness of fetoneonatal health care [From admission to discharge, study inclusion to one year postpartum]
based on secondary data provided by Health insurance funds
- evaluation of ungoing processes during the fetoneontal health care pathway: participation of health care provider [From admission to discharge, study inclusion to one year postpartum]
based on secondary data provided by Health insurance funds
- evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees [From admission to discharge, study inclusion to one year postpartum]
based on secondary data provided by Health insurance funds
- evaluation of ungoing processes during the fetoneontal health care pathway: the pathway's maintenance being long term part of routine health care [From admission to discharge, study inclusion to one year postpartum]
based on secondary data provided by Health insurance funds
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, minim. 10 weeks of pregnancy, maximum 36 weeks of pregnancy
-
anamnestic risk of preeclempsia or fetal growth restriction
-
being part of the project region
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin | Dresden | Saxony | Germany | 01307 |
| 2 | Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin | Jena | Thuringia | Germany | 07747 |
Sponsors and Collaborators
- Technische Universität Dresden
- Jena University Hospital
Investigators
- Study Director: Mario Rüdiger, Prof. Dr, Technische Univeristät Dresden
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- FetoNeonatPfad