Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

NCT ID: NCT03862976

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-03-23

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

computerized cardiotocography

computerized cardiotocography

Group Type: EXPERIMENTAL

computerized cardiotocography

Intervention Type: DIAGNOSTIC_TEST

computerized cardiotocography (C-CTG)

standard cardiotocography

standard cardiotocography non stresstest

Group Type: ACTIVE_COMPARATOR

computerized cardiotocography

Intervention Type: DIAGNOSTIC_TEST

computerized cardiotocography (C-CTG)

Interventions

computerized cardiotocography

computerized cardiotocography (C-CTG)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• IUGR

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Napoli, , Italy

Countries

Italy

Other Identifiers

371/18

Identifier Type: -

Identifier Source: org_study_id