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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04514276
• Other study ID #: FetoNeonatPfad
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 828
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Maternal Care for Known or Suspected Poor Fetal Growth
• Pre-Eclampsia

Intervention

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.

Locations

Country	Name	City	State
Germany	Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin	Dresden	Saxony
Germany	Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of patients' safety: maternal pre-eclampsia rate	self-designed questionnaire, health information	through study completion, an average of 1 year and 7 months
Primary	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
Primary	Evaluation of patients' safety: maternal morbidity	self-designed questionnaire, health information	through study completion, an average of 1 year and 7 months
Primary	Evaluation of patients' safety: infantil morbidity	self-designed questionnaire, health information	through study completion, an average of 1 year and 7 months
Primary	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
Primary	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
Primary	Evaluation of patient's access to treatment and satisfaction	self-designed questionnaire	through study completion, an average of 1 year and 7 months
Primary	claim of the health services	based on self-designed questionnaires	From admission to discharge, study inclusion to one year postpartum)
Primary	prohibition of employment	based on self-designed questionnaires	From admission to discharge, study inclusion to one year postpartum)
Primary	duration of unemployability	based on self-designed questionnaires	From admission to discharge, study inclusion to one year postpartum)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Medizinische Fakultät DresdenKlinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin