Perinatal mortality and morbidity - Health condition of the (unborn) child Death and disease of a newborn or fetus
Conditions
Interventions
Eligible women will be prospectively included in the cohort receiving standard 
treatment: CTG monitoring intermittent up to three times a day. From these 
eligible women, a random sample (464) of the prospective cohort (511) will be 
offered to receive a new monitoring method: 24/7 eCTG monitoring with NFMS. In 
order to strengthen the comparison between the two groups (continous CTG and standard 
treatment), additional data from 1400 women who received standard treatment in 
2014-2019 will be collected retrospectively.
Sponsors
Máxima MC
Eligibility
Inclusion criteria
Inclusion criteria: >=18 years old, Singleton pregnancy >=23+0 weeks of gestation,Requiring hospitalization to the OHC for maternal or fetal surveillance, Parents wishing for fetal monitoring
Exclusion criteria
Exclusion criteria: Multiple pregnancy, insufficient knowledge of Dutch or English language , Contraindications to abdominal patch placement (dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper), women connected to an external or implanted electrical stimulator (e.g. a pacemaker - exclusion due to possible signal interference), Fetal and/or maternal cardiac disease (i.e. arrhythmia, congenital defect), Treatment plan (with intervention planned) already made before inclusion is completed, and women admitted with a clinical diagnosis of sepsis with hypotension (i.e. septic shock).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a composite of perinatal mortality or major neonatal morbidity until hospital discharge. Major neonatal morbidity is defined as either: Intraventricular hemorrhage (IVH) grade three or more, Periventricular leukomalacia (PVL) grade two or more, Moderate or severe bronchopulmonary dysplasia (BPD), Necrotizing enterocolitis (NEC) grade two or more, or Retinopathy of prematurity (ROP) necessitating laser therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal mortality, neonatal morbidity, satisfaction for both patient and caregiver, duration of pregnancy, switch of monitoring method, duration of admission to the OHC, timing (planned or emergency) and number of obstetric interventions (such as caesarean section), and admission and duration of admission to the NICU (neonatal intensive care unit). Additional objectives: The collected NFMS and demographic data will be used to develop and verify a mathematical model for the prediction of time until (preterm) birth, which may be used in clinical practice to reduce unnecessary OHC admissions and facilitate a better timing of interventions. Furthermore, data collected in this study (NFMS, accelerometric, annotated ultrasound) will be used for the development and verification of a mathematical model for the automated detection of fetal movements in NFMS data. This latter model might provide new opportunities in non-invasive monitoring of fetal health. | — |
Countries
Netherlands
Contacts
Public ContactK Peters
Máxima MC
Outcome results
None listed