Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Study Overview
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Brief Summary
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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.

Official Title
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Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Conditions
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Cesarean Section

Intervention / Treatment
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* Diagnostic Test: computerized cardiotocography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with singleton gestation 18 years to 50 years High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia Exclusion Criteria: - IUGR

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: computerized cardiotocography<br>computerized cardiotocography | Diagnostic Test: computerized cardiotocography<br>* computerized cardiotocography (C-CTG)<br>|
| Active Comparator: standard cardiotocography<br>standard cardiotocography non stresstest | Diagnostic Test: computerized cardiotocography<br>* computerized cardiotocography (C-CTG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean section | incidence of cesarean section | at the time of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational age at delivery | week of delivery | at the time of delivery | 
| admission to neonatal intensive care unit | admission to neonatal intensive care unit | at the time of delivery | 
| birth weight | neonatal birth weight at delivery | at the time of delivery | 
| APGAR score at delivery | APGAR score at delivery | at the time of delivery | 
| neonatal death | death of a live neonates within 28 days of life | 28 days of live of the neonate |