Evaluation of a computer system that alerts heathcare professionals to changes in foetal monitoring signals acquired during labour
Not Applicable
Completed
- Conditions
- Intrapartum foetal hypoxiaPregnancy and ChildbirthMaternal care for other known or suspected fetal problems
- Registration Number
- ISRCTN42314164
- Lead Sponsor
- niversity of Porto (Universidade do Porto) (Portugal)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 8000
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
Does not meet inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of foetal metabolic acidosis, defined as newborn umbilical artery pH <7.05 and BDecf >12 mmol/L.
- Secondary Outcome Measures
Name Time Method 1. Overall rates of caesarean section and caesarean section for non-reassuring foetal state<br>2. Overall rates of instrumental vaginal delivery and instrumental vaginal delivery for non-reassuring foetal state<br>3. Foetal blood sampling rates<br>4. Incidence of 5-minute Apgar score <7<br>5. Need for neonatal intensive care unit admission<br>6. Incidence of moderate and severe neonatal encephalopathy with a hypoxic marker<br>7. Perinatal death<br>8. Rate of delayed interventions (interval between red alerts [intervention arm]/offline analysis [control arm] and delivery in metabolic acidosis cases)<br>8. Tracing quality and signal loss