Pre-EclampsiaNCT04514276
Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway
A study testing consecutive fetoneonatal healthcare pathway in people with Pre-Eclampsia and Intrauterine Growth Restriction, run by Technische Universität Dresden at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-Eclampsia, Intrauterine Growth Restriction, Maternal Care for Known or Suspected Poor Fetal Growth
- What is being tested?
- consecutive fetoneonatal healthcare pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Fakultät Dresden Klinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie & Pädiatrische Intensivmedizin
Dresden, Saxony, 01307
Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin
Jena, Thuringia, 07747
About this study
Official title: 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)
Read the 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.
- Conditions
- Pre-Eclampsia, Intrauterine Growth Restriction, Maternal Care for Known or Suspected Poor Fetal Growth
- Being tested
- consecutive fetoneonatal healthcare pathway
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consecutive fetoneonatal healthcare pathwayOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| consecutive fetoneonatal healthcare | Experimental | 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. Receives: Other: consecutive fetoneonatal healthcare pathway |
| standard fetoneonatal healthcare | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients' safety: maternal pre-eclampsia rate
self-designed questionnaire, health information
Measured: 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
Measured: through study completion, an average of 1 year and 7 months
Evaluation of patients' safety: maternal morbidity
self-designed questionnaire, health information
Measured: through study completion, an average of 1 year and 7 months
Evaluation of patients' safety: infantil morbidity
self-designed questionnaire, health information
Measured: 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)
Measured: 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)
Measured: through study completion, an average of 1 year and 7 months
Evaluation of patient's access to treatment and satisfaction
self-designed questionnaire
Measured: through study completion, an average of 1 year and 7 months
claim of the health services
based on self-designed questionnaires
Measured: From admission to discharge, study inclusion to one year postpartum)
prohibition of employment
based on self-designed questionnaires
Measured: From admission to discharge, study inclusion to one year postpartum)
duration of unemployability
based on self-designed questionnaires
Measured: From admission to discharge, study inclusion to one year postpartum)
Secondary outcomes (6)
health economical evaluation
cost-benefit-analysis of patients' outcome in relation to supply costs based on secondary data provided by Health insurance funds
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From admission to discharge, study inclusion to one year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jun 2020
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 828 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital
- Responsible party
- Sponsor
- Investigators
- Mario Rüdiger, Prof. Dr, Study director, Technische Univeristät Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514276
- Sponsor's protocol ID
- FetoNeonatPfad
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data protection reasons
Publications
Epple F, Reichert J, Rudiger M, Birdir C, Mense L. Early psycho-social support of pregnant women at risk for preeclampsia and fetal intrauterine growth restriction. BMC Pregnancy Childbirth. 2025 Oct 27;25(1):1142. doi: 10.1186/s12884-025-08363-9.
PubMed 41146068
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inter- and Multidisciplinary, Cross-sectoral Feto-neonatal Pathway for High-risk Pregnant Women Because of Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT04514276
- Acronym / sponsor ID
- FetoNeonatPfad
- Conditions
- Pre-Eclampsia, Intrauterine Growth Restriction, Maternal Care for Known or Suspected Poor Fetal Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 828 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Jena University Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| consecutive fetoneonatal healthcare | Experimental | Other: consecutive fetoneonatal healthcare pathwayinclusion 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. |
| standard fetoneonatal healthcare | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | consecutive fetoneonatal healthcare |
Primary outcome
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: 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 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)
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
prohibition of employment
Time frame: From admission to discharge, study inclusion to one year postpartum)
based on self-designed questionnaires
duration of unemployability
Time frame: From admission to discharge, study inclusion to one year postpartum)
based on self-designed questionnaires
6 secondary outcomes
health economical evaluation
Time frame: From admission to discharge, study inclusion to one year postpartum
evaluation of ungoing processes during the fetoneontal health care pathway: target patients
Time frame: 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
Time frame: 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
Time frame: From admission to discharge, study inclusion to one year postpartum
evaluation of ungoing processes during the fetoneontal health care pathway: implementation of participating employees
Time frame: 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
Time frame: From admission to discharge, study inclusion to one year postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 41146068Epple F, Reichert J, Rudiger M, Birdir C, Mense L. Early psycho-social support of pregnant women at risk for preeclampsia and fetal intrauterine growth restriction. BMC Pregnancy Childbirth. 2025 Oct 27;25(1):1142. doi: 10.1186/s12884-025-08363-9.
- Medizinische Fakultät DresdenKlinik und Poliklinik für Kinder- und Jugendmedizin / Neonatologie \& Pädiatrische IntensivmedizinLink provided by the sponsor.
- Individual participant dataSharing planned: No. data protection reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Rüdiger, Prof. Dr study director
Technische Univeristät Dresden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consecutive fetoneonatal healthcare pathway in people with Pre-Eclampsia and Intrauterine Growth Restriction, run by Technische Universität Dresden at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of patients' safety: maternal pre-eclampsia rate (time frame: through study completion, an average of 1 year and 7 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.