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

Technische Universität Dresden

Status: Active, not recruiting

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

Treatments: Other: consecutive fetoneonatal healthcare pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT04514276

FetoNeonatPfad

Details and patient eligibility

About

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)

Full 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.

Enrollment: 828 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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828 participants in 2 patient groups

consecutive fetoneonatal healthcare

Experimental group

Description:

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.

Treatment:

Other: consecutive fetoneonatal healthcare pathway

standard fetoneonatal healthcare

No Intervention group

Description:

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.