Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedOctober 8, 2020
October 1, 2020
9 months
March 1, 2019
October 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
cesarean section
incidence of cesarean section
at the time of delivery
Secondary Outcomes (5)
gestational age at delivery
at the time of delivery
admission to neonatal intensive care unit
at the time of delivery
birth weight
at the time of delivery
APGAR score at delivery
at the time of delivery
neonatal death
28 days of live of the neonate
Study Arms (2)
computerized cardiotocography
EXPERIMENTALcomputerized cardiotocography
standard cardiotocography
ACTIVE COMPARATORstandard cardiotocography non stresstest
Interventions
computerized cardiotocography (C-CTG)
Eligibility Criteria
You may qualify if:
- Women with singleton gestation
- years to 50 years
- High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia
You may not qualify if:
- \- IUGR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gabriele Saccone
Napoli, 80129, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
March 1, 2019
First Posted
March 5, 2019
Study Start
March 25, 2019
Primary Completion
December 15, 2019
Study Completion
March 23, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
not planned