Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Cesarean Section Clinical Trial

Official title:

Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862976
• Other study ID #: 371/18
• Status: Completed
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: October 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 23, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women with singleton gestation

• 18 years to 50 years

• High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia

Exclusion Criteria:

• IUGR

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Diagnostic Test:
• computerized cardiotocography
computerized cardiotocography (C-CTG)

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cesarean section	incidence of cesarean section	at the time of delivery
Secondary	gestational age at delivery	week of delivery	at the time of delivery
Secondary	admission to neonatal intensive care unit	admission to neonatal intensive care unit	at the time of delivery
Secondary	birth weight	neonatal birth weight at delivery	at the time of delivery
Secondary	APGAR score at delivery	APGAR score at delivery	at the time of delivery
Secondary	neonatal death	death of a live neonates within 28 days of life	28 days of live of the neonate