Cesarean Section
Conditions
Brief summary
Electronic fetal hear rate monitoring (EFM), or cardiotocography (CTG), records changes in fetal heart rate and their temporal relationship to uterine contraction. It has been developed with the aim of detecting fetal hypoxia during labor and hence to prevent metabolic acidosis. Despite being the standard for intrapartum management, this technique, significantly increase the operative delivery rate, and is associated only with less seizures as neonatal benefit. Another concern is also the variability in the interpretation. Several techniques have been studied in order to decrease the high false positive rate. Fetal ST waveform analysis (STAN) has been studied combined with CTG. A recent meta-analysis of randomized trials, however, showed that STAN during labor did not improve perinatal outcomes or decrease operative delivery rates, except for a 9% decrease in operative vaginal delivery.Comparisons of visual and computerized interpretation of EFM have also been reported. However, whether or fetal monitoring with computer analysis improve perinatal outcomes is still subject of debate. Thus, we aim to evaluate whether intrapartum fetal monitoring with computer analysis increase the incidence of obstetric intervention when compared with visual analysis through a single-center randomized controlled trial.
Interventions
DIAGNOSTIC_TESTcomputerized cardiotocography
computerized cardiotocography (C-CTG)
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women with singleton gestation * 18 years to 50 years * High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia
Exclusion criteria
\- IUGR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cesarean section | at the time of delivery | incidence of cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gestational age at delivery | at the time of delivery | week of delivery |
| admission to neonatal intensive care unit | at the time of delivery | admission to neonatal intensive care unit |
| birth weight | at the time of delivery | neonatal birth weight at delivery |
| APGAR score at delivery | at the time of delivery | APGAR score at delivery |
| neonatal death | 28 days of live of the neonate | death of a live neonates within 28 days of life |
Countries
Italy
Outcome results
None listed