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

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
consecutive fetoneonatal healthcare pathway
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pre-Eclampsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin
  • Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

consecutive fetoneonatal healthcare

standard fetoneonatal healthcare

Arm 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.

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.

Outcomes

Primary Outcome Measures

Evaluation of patients' safety: maternal pre-eclampsia rate
self-designed questionnaire, health information
Evaluation of patients' safety: newborn's birthweight adjusted by gestational age
self-designed questionnaire, health information
Evaluation of patients' safety: maternal morbidity
self-designed questionnaire, health information
Evaluation of patients' safety: infantil morbidity
self-designed questionnaire, health information
Evaluation of patients' safety: Quality of life
Questionnaire: Quality of Life (Angermayer, Kilin & Matschinger, 2000)
Evaluation of patients' safety: attachment behavior
Questionnaire: Postpartum Bonding Questionnaire (Reck et al., 2006)
Evaluation of patient's access to treatment and satisfaction
self-designed questionnaire
claim of the health services
based on self-designed questionnaires
prohibition of employment
based on self-designed questionnaires
duration of unemployability
based on self-designed questionnaires

Secondary Outcome Measures

health economical evaluation
cost-benefit-analysis of patients' outcome in relation to supply costs based on secondary data provided by Health insurance funds
evaluation of ungoing processes during the fetoneontal health care pathway: target patients
based on secondary data provided by Health insurance funds
evaluation of ungoing processes during the fetoneontal health care pathway: effectiveness of fetoneonatal health care
based on secondary data provided by Health insurance funds
evaluation of ungoing processes during the fetoneontal health care pathway: participation of health care provider
based on secondary data provided by Health insurance funds
evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees
based on secondary data provided by Health insurance funds
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

Full Information

First Posted
June 22, 2020
Last Updated
February 27, 2023
Sponsor
Technische Universität Dresden
Collaborators
Jena University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04514276
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
Jena University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Intrauterine Growth Restriction, Maternal Care for Known or Suspected Poor Fetal Growth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
828 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
consecutive fetoneonatal healthcare
Arm Type
Experimental
Arm 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.
Arm Title
standard fetoneonatal healthcare
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
consecutive fetoneonatal healthcare pathway
Intervention Description
(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.
Primary Outcome Measure Information:
Title
Evaluation of patients' safety: maternal pre-eclampsia rate
Description
self-designed questionnaire, health information
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patients' safety: newborn's birthweight adjusted by gestational age
Description
self-designed questionnaire, health information
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patients' safety: maternal morbidity
Description
self-designed questionnaire, health information
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patients' safety: infantil morbidity
Description
self-designed questionnaire, health information
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patients' safety: Quality of life
Description
Questionnaire: Quality of Life (Angermayer, Kilin & Matschinger, 2000)
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patients' safety: attachment behavior
Description
Questionnaire: Postpartum Bonding Questionnaire (Reck et al., 2006)
Time Frame
through study completion, an average of 1 year and 7 months
Title
Evaluation of patient's access to treatment and satisfaction
Description
self-designed questionnaire
Time Frame
through study completion, an average of 1 year and 7 months
Title
claim of the health services
Description
based on self-designed questionnaires
Time Frame
From admission to discharge, study inclusion to one year postpartum)
Title
prohibition of employment
Description
based on self-designed questionnaires
Time Frame
From admission to discharge, study inclusion to one year postpartum)
Title
duration of unemployability
Description
based on self-designed questionnaires
Time Frame
From admission to discharge, study inclusion to one year postpartum)
Secondary Outcome Measure Information:
Title
health economical evaluation
Description
cost-benefit-analysis of patients' outcome in relation to supply costs based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum
Title
evaluation of ungoing processes during the fetoneontal health care pathway: target patients
Description
based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum
Title
evaluation of ungoing processes during the fetoneontal health care pathway: effectiveness of fetoneonatal health care
Description
based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum
Title
evaluation of ungoing processes during the fetoneontal health care pathway: participation of health care provider
Description
based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum
Title
evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees
Description
based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum
Title
evaluation of ungoing processes during the fetoneontal health care pathway: the pathway's maintenance being long term part of routine health care
Description
based on secondary data provided by Health insurance funds
Time Frame
From admission to discharge, study inclusion to one year postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Rüdiger, Prof. Dr
Organizational Affiliation
Technische Univeristät Dresden
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data protection reasons
Links:
URL
https://www.uniklinikum-dresden.de/de/das-klinikum/kliniken-polikliniken-institute/kik/bereiche/fachbereiche/neonatologie-its
Description
Medizinische Fakultät DresdenKlinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin

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

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