Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Federico II University

Status: Completed

Conditions: Cesarean Section

Treatments: Diagnostic Test: computerized cardiotocography

Study type: Interventional

Funder types: Other

Identifiers

NCT03862976

371/18

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with singleton gestation
• 18 years to 50 years
• High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion criteria

• IUGR

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

computerized cardiotocography

Experimental group

Description:

computerized cardiotocography

Treatment:

Diagnostic Test: computerized cardiotocography

standard cardiotocography

Active Comparator group

Description:

standard cardiotocography non stresstest

Treatment:

Diagnostic Test: computerized cardiotocography