Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway for High-risk Pregnant Women Because of Fetal Growth Restriction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 828
- Locations
- 4
- Primary Endpoint
- Evaluation of patients' safety: newborn's birthweight adjusted by gestational age
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Evaluation of patients' safety: newborn's birthweight adjusted by gestational age
Time Frame: through study completion, an average of 1 year and 7 months
self-designed questionnaire, health information
Evaluation of patients' safety: maternal morbidity
Time Frame: through study completion, an average of 1 year and 7 months
self-designed questionnaire, health information
Evaluation of patients' safety: infantil morbidity
Time Frame: through study completion, an average of 1 year and 7 months
self-designed questionnaire, health information
Evaluation of patients' safety: Quality of life
Time Frame: through study completion, an average of 1 year and 7 months
Questionnaire: Quality of Life (Angermayer, Kilin \& Matschinger, 2000)
Evaluation of patient's access to treatment and satisfaction
Time Frame: through study completion, an average of 1 year and 7 months
self-designed questionnaire
claim of the health services
Time Frame: From admission to discharge, study inclusion to one year postpartum)
based on self-designed questionnaires
Evaluation of patients' safety: maternal pre-eclampsia rate
Time Frame: through study completion, an average of 1 year and 7 months
self-designed questionnaire, health information
Evaluation of patients' safety: attachment behavior
Time Frame: through study completion, an average of 1 year and 7 months
Questionnaire: Postpartum Bonding Questionnaire (Reck et al., 2006)
duration of unemployability
Time Frame: From admission to discharge, study inclusion to one year postpartum)
based on self-designed questionnaires
prohibition of employment
Time Frame: From admission to discharge, study inclusion to one year postpartum)
based on self-designed questionnaires
Secondary Outcomes
- 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)
- 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)
- evaluation of ungoing processes during the fetoneontal health care pathway: target patients(From admission to discharge, study inclusion to one year postpartum)
- health economical evaluation(From admission to discharge, study inclusion to one year postpartum)
- evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees(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(From admission to discharge, study inclusion to one year postpartum)