High-risk pregnant women and sick newborns and their families cared for in a partner facility (outpatient practice for prenatal diagnostics and prenatal medicine or hospital)
Conditions
Interventions
Group 1: Intervention group (care with supportive telemedicine):
The health care network "SAFE BIRTH" unites outpatient and inpatient facilities at different levels of care in Saxony with the goal of
Prenatal jour-fixe (recorded findings are discussed in a virtual room within a week of the initial diagnosis - without the participation of the pregnant woman)
Determination of a care plan, if necessary including other specialist disciplines
Psychosocial counseling (the psychosocial team of the Perinatal Center at the University Hospital contacts the pregnant woman by telephone)
Feto-neonatal board meeting (review and adjustment of the care plan to current findings)
Intervention bundle 2 (IB#2) - Neonatal resuscitation: Immediate teleconsultation during resuscitation of newbo
if necessary, parallel alerting of the neonatal emergency physician (NNA), who remains informed about the resuscitation via push messages
resuscitation debriefing
Intervention bundle 3 (IB#3) - Neonatal Antibiotic Stewardship: Regular or short-term scheduled infectious disease teleconsultations between the partner clinic a
Sponsors
Zentrum für Feto-Neonatale Gesundheit, Universitätsklinikum Carl Gustav Carus und medizinische Fakultät der TU Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Target population of pregnant women/newborns: IB#1: Pregnant woman seen by a participating prenatal physician in outpatient practices who meets one of the following criteria: - Suspected severe fetal organ malformations, especially of the heart, brain, gastrointestinal or genitourinary tract, - Suspected complex genetic disease of the fetus, such as trisomy 13 or 18, - Indication of prognosis of the fetus incompatible with life, - Maternal diseases with possible effects on the fetus, such as gestational diabetes or maternal tumor disease; IB#2: Newborns cared for in the delivery room or admitted as an inpatient, who meets one of the two criteria at the participating hospital: - need for resuscitation immediately after birth, defined as need for ventilation, chest compressions, or medication application, or presence of severe asphyxia (umbilical pH 0.5; IB#3: Inpatient newborns admitted to the participating hospital who meet either of the two criteria: - Antibiotic therapy, - Positive microbiological screening result; IB#4: Premature or sick newborn admitted as an inpatient at the participating hospitals who meets one of the two criteria: - Care at the perinatal center and transfer back to the partner hospital close to home; - Care at the partner hospital and suspected need for transfer to the perinatal center; IB#5: Families of newborns cared for at a partner hospital who possibly need psycho-social support due to an inpatient stay of the newborn of at least 2 days; Target group medical staff: - Involved in the care of pregnant women/newborns who meet the above criteria - Medical work at a partner facility (participating hospital or outpatient prenatal practice)
Exclusion criteria
Exclusion criteria: - Pregnant woman younger than 18 years - IB#5 and psychosocial counselling of IB#1 and IB#4: German language skills not sufficient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IB#1: Proportion of patients who have a care plan with a multiprofessional recommendation for postnatal care and psychosocial counseling within one week. IB#2: Proportion of newborns with a neonatologist present in the delivery room < 15 minutes postnatally (including virtually, if applicable). IB#3: Proportion of newborns in whom antibiotic could be discontinued within 48 hours (in case of CrP, IL-6 negative and negative blood culture) or antibiotic therapy was given for 6 days (in case of positive blood culture) with antibiotic according to resistogram. IB#4: Proportion of newborns cared for at the Perinatal Center of the University Hospital from the region (according to zip code list) who were discharged from a hospital close to home final. IB#5: Proportion of patients who received at least one psychosocial support program. | — |
Secondary
| Measure | Time frame |
|---|---|
| Care close to home: IB#1: - Proportion of patients referred to the Perinatal Center of the University Hospital (SHI routine data of the participating health insurance company) - Proportion of patients who gave birth in a defined facility level (project database, SHI routine data of the participating health insurance company) - Proportion of patients and mean number of virtual feto-neonatal board meetings (project database) - Frequency of disciplines involved in virtual feto-neonatal board meetings (project database) - Proportion of patients with psychosocial consultation within two weeks after diagnosis or directly at patient contact (project database) - Proportion of patients who make use of further offers of help (project database) - Maternal risks and complications during inpatient stay measured by ICD and OPS codes (SHI routine data of the participating health insurance company) IB#2: - Number of postnatal transports (project database) - Proportion of transferred newborns (project database) - On transport: time of neonatologist at partner hospital (project database) - Condition of newborn during transport measured by body temperature and blood glucose in each case in partner hospital and Perinatal Center of the University Hospital (project database) - Time (in minutes) until a neonatologist is present in the delivery room postnatally (also virtually, if necessary) (project database) - Proportion of infants with hypoglycemia in the first 24 hours (project database) - Number of teleconsultation in the delivery room (project database) - Proportion of newborns with teleconsil in case of deterioration of condition on ward (project database) - Number of deceased newborns (project database, SHI routine data of the participating health insurance company) IB#3: - Proportion of newborns with antibiotic therapy (project database) - Average duration of antibiotic therapy (project database) - Proportion of newborns whose therapy was terminated after 36- | — |
Countries
Germany
Contacts
Public ContactMario Rüdiger
Zentrum für Feto-Neonatale Gesundheit, Universitätsklinikum Carl Gustav Carus und medizinische Fakultät der TU Dresden
Outcome results
None listed