Clinical trial NCT04514276: Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway
Official title: Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway for High-risk Pregnant Women Because of Fetal Growth Restriction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Intrauterine Growth Restriction
Maternal Care for Known or Suspected Poor Fetal Growth
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Jena University Hospital
First posted: 2020-08-14
Enrollment: 828
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of patients' safety: maternal pre-eclampsia rate
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patients' safety: newborn's birthweight adjusted by gestational age
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patients' safety: maternal morbidity
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patients' safety: infantil morbidity
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patients' safety: Quality of life
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patients' safety: attachment behavior
timeFrame: through study completion, an average of 1 year and 7 months
measure: Evaluation of patient's access to treatment and satisfaction
timeFrame: through study completion, an average of 1 year and 7 months
measure: claim of the health services
timeFrame: From admission to discharge, study inclusion to one year postpartum)
measure: prohibition of employment
timeFrame: From admission to discharge, study inclusion to one year postpartum)
measure: duration of unemployability
timeFrame: From admission to discharge, study inclusion to one year postpartum)
Secondary outcomes:
measure: health economical evaluation
timeFrame: From admission to discharge, study inclusion to one year postpartum
measure: evaluation of ungoing processes during the fetoneontal health care pathway: target patients
timeFrame: From admission to discharge, study inclusion to one year postpartum
measure: evaluation of ungoing processes during the fetoneontal health care pathway: effectiveness of fetoneonatal health care
timeFrame: From admission to discharge, study inclusion to one year postpartum
measure: evaluation of ungoing processes during the fetoneontal health care pathway: participation of health care provider
timeFrame: From admission to discharge, study inclusion to one year postpartum
measure: evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees
timeFrame: From admission to discharge, study inclusion to one year postpartum
measure: evaluation of ungoing processes during the fetoneontal health care pathway: the pathway's maintenance being long term part of routine health care
timeFrame: From admission to discharge, study inclusion to one year postpartum
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin
state: Saxony
city: Jena
country: Germany
facility: Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin
state: Thuringia
Study officials:
affiliation: Technische Univeristät Dresden
name: Mario Rüdiger, Prof. Dr
role: STUDY_DIRECTOR
References: