Intrapartum foetal hypoxia Pregnancy and Childbirth Maternal care for other known or suspected fetal problems
Conditions
Interventions
Continuous foetal monitoring during labour with computer analysis by the Omniview-SisPorto 3.5 system vs continuous intrapartum monitoring as previously performed.
Sponsors
University of Porto (Universidade do Porto) (Portugal)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women, aged more than 16 years 2. Able to provide written informed consent 3. Singleton pregnancy 4. Gestation of 36 or more completed weeks 5. Cephalic presentation 6. No known major foetal malformations 7. In active labour but not in active second stage 8. No known contraindication to vaginal delivery 9. Clinical decision made to perform continuous cardiotocography (CTG) monitoring
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of foetal metabolic acidosis, defined as newborn umbilical artery pH 12 mmol/L. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall rates of caesarean section and caesarean section for non-reassuring foetal state 2. Overall rates of instrumental vaginal delivery and instrumental vaginal delivery for non-reassuring foetal state 3. Foetal blood sampling rates 4. Incidence of 5-minute Apgar score <7 5. Need for neonatal intensive care unit admission 6. Incidence of moderate and severe neonatal encephalopathy with a hypoxic marker 7. Perinatal death 8. Rate of delayed interventions (interval between red alerts [intervention arm]/offline analysis [control arm] and delivery in metabolic acidosis cases) 8. Tracing quality and signal loss | — |
Countries
United Kingdom
Outcome results
None listed