Cesarean SectionNCT03862976
Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
A study testing computerized cardiotocography in people with Cesarean Section, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- computerized cardiotocography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with singleton gestation
- 18 years to 50 years
- High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia
Who cannot join
- IUGR
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- computerized cardiotocography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized cardiotocographyDiagnostic test
computerized cardiotocography (C-CTG)
| Study group | Role | What they receive |
|---|---|---|
| computerized cardiotocography | Experimental | computerized cardiotocography Receives: Diagnostic Test: computerized cardiotocography |
| standard cardiotocography | Active comparator | standard cardiotocography non stresstest Receives: Diagnostic Test: computerized cardiotocography |
What is being measured
The primary outcome is the main question the study is designed to answer.
cesarean section
incidence of cesarean section
Measured: at the time of delivery
Secondary outcomes (5)
gestational age at delivery
week of delivery
Measured: at the time of delivery
admission to neonatal intensive care unit
admission to neonatal intensive care unit
Measured: at the time of delivery
birth weight
neonatal birth weight at delivery
Measured: at the time of delivery
APGAR score at delivery
APGAR score at delivery
Measured: at the time of delivery
neonatal death
death of a live neonates within 28 days of life
Measured: 28 days of live of the neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start25 Mar 2019
- Primary completion15 Dec 2019
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862976
- Sponsor's protocol ID
- 371/18
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not planned
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antepartum Cardiotocography With and Without Computer Analysis in High Risk Pregnancies
- ClinicalTrials.gov ID
- NCT03862976
- Acronym / sponsor ID
- 371/18
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computerized cardiotocography | Experimental | Diagnostic Test: computerized cardiotocographycomputerized cardiotocography |
| standard cardiotocography | Active comparator | Diagnostic Test: computerized cardiotocographystandard cardiotocography non stresstest |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with singleton gestation
- 18 years to 50 years
- High risk pregnancies: DM, or GDM, or hypertension, or preeclampsia
Key exclusion criteria (1 listed)
- IUGR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computerized cardiotocographycomputerized cardiotocography (C-CTG) | Diagnostic test | computerized cardiotocography, standard cardiotocography |
Primary outcome
cesarean section
Time frame: at the time of delivery
incidence of cesarean section
5 secondary outcomes
gestational age at delivery
Time frame: at the time of delivery
admission to neonatal intensive care unit
Time frame: at the time of delivery
birth weight
Time frame: at the time of delivery
APGAR score at delivery
Time frame: at the time of delivery
neonatal death
Time frame: 28 days of live of the neonate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No. not planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized cardiotocography in people with Cesarean Section, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cesarean section (time frame: at the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.