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

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Pre-Eclampsia; Intrauterine Growth Restriction; Maternal Care for Known or Suspected Poor Fetal Growth
• Intervention / Treatment: Other: consecutive fetoneonatal healthcare pathway

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 Type: Interventional
• Enrollment (Anticipated): 828
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Rüdiger, Prof. Dr.; Phone Number: +49 351 458 13640; Email: Mario.ruediger@uniklinikum-dresden.de
• Study Contact Backup: Name: Marie Avinov; Phone Number: +49 (0) 351/ 458 - 18881; Email: Marie.Avinov@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: consecutive fetoneonatal healthcare; 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; (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.
No Intervention: standard fetoneonatal healthcare; 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?

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Jena University Hospital
• Investigators: Study Director: Mario Rüdiger, Prof. Dr, Technische Univeristät Dresden

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Growth Disorders; Eclampsia; Pre-Eclampsia; Fetal Growth Retardation
• Other Study ID Numbers: FetoNeonatPfad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data protection reasons

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No