Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
- Conditions
- Cesarean Section
- Interventions
- Diagnostic Test: computerized cardiotocography
- Registration Number
- NCT03862976
- Lead Sponsor
- Federico II University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 28
- Women with singleton gestation
- 18 years to 50 years
- High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia
- IUGR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description computerized cardiotocography computerized cardiotocography computerized cardiotocography standard cardiotocography computerized cardiotocography standard cardiotocography non stresstest
- Primary Outcome Measures
Name Time Method cesarean section at the time of delivery incidence of cesarean section
- Secondary Outcome Measures
Name Time Method birth weight at the time of delivery neonatal birth weight at delivery
neonatal death 28 days of live of the neonate death of a live neonates within 28 days of life
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
APGAR score at delivery at the time of delivery APGAR score at delivery
Trial Locations
- Locations (1)
Gabriele Saccone
🇮🇹Napoli, Italy