Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway for High-risk Pregnant Women Because of Fetal Growth Restriction

Conditions
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Pre-Eclampsia, Intrauterine Growth Restriction, Maternal Care for Known or Suspected Poor Fetal Growth

Intervention / Treatment
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* Other: consecutive fetoneonatal healthcare pathway


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: consecutive fetoneonatal healthcare<br>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<br>* (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.<br>|
| No Intervention: standard fetoneonatal healthcare<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of patients' safety: maternal pre-eclampsia rate | self-designed questionnaire, health information | through study completion, an average of 1 year and 7 months | 
| Evaluation of patients' safety: newborn's birthweight adjusted by gestational age | self-designed questionnaire, health information | through study completion, an average of 1 year and 7 months | 
| Evaluation of patients' safety: maternal morbidity | self-designed questionnaire, health information | through study completion, an average of 1 year and 7 months | 
| Evaluation of patients' safety: infantil morbidity | self-designed questionnaire, health information | through study completion, an average of 1 year and 7 months | 
| Evaluation of patients' safety: Quality of life | Questionnaire: Quality of Life (Angermayer, Kilin & Matschinger, 2000) | through study completion, an average of 1 year and 7 months | 
| Evaluation of patients' safety: attachment behavior | Questionnaire: Postpartum Bonding Questionnaire (Reck et al., 2006) | through study completion, an average of 1 year and 7 months | 
| Evaluation of patient's access to treatment and satisfaction | self-designed questionnaire | through study completion, an average of 1 year and 7 months | 
| claim of the health services | based on self-designed questionnaires | From admission to discharge, study inclusion to one year postpartum) | 
| prohibition of employment | based on self-designed questionnaires | From admission to discharge, study inclusion to one year postpartum) | 
| duration of unemployability | based on self-designed questionnaires | From admission to discharge, study inclusion to one year postpartum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health economical evaluation | cost-benefit-analysis of patients' outcome in relation to supply costs based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum | 
| evaluation of ungoing processes during the fetoneontal health care pathway: target patients | based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum | 
| evaluation of ungoing processes during the fetoneontal health care pathway: effectiveness of fetoneonatal health care | based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum | 
| evaluation of ungoing processes during the fetoneontal health care pathway: participation of health care provider | based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum | 
| evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees | based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum | 
| evaluation of ungoing processes during the fetoneontal health care pathway: the pathway's maintenance being long term part of routine health care | based on secondary data provided by Health insurance funds | From admission to discharge, study inclusion to one year postpartum |