NCT04514276

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
828

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3.8 years

First QC Date

June 22, 2020

Last Update Submit

February 27, 2023

Conditions

Pre-EclampsiaIntrauterine Growth RestrictionMaternal Care for Known or Suspected Poor Fetal Growth

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (6)

  • health economical evaluation

    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

  • 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: participation of health care provider

    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

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

consecutive fetoneonatal healthcare

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Jena Klinik für Kinder- und Jugendmedizin

Jena, Thuringia, 07747, Germany

Location

Related Publications (1)

  • 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.

    PMID: 41146068DERIVED

Related Links

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mario Rüdiger, Prof. Dr

    Technische Univeristät Dresden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

August 14, 2020

Study Start

June 1, 2020

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

data protection reasons

Locations

DE(2)