Fetal MovementNCT04397874
Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.
An observational study of Fetal Movement, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Movement
- What is being tested?
- ; Computerized cardiotocography (cCTG)
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 1 Sep 2025
- Phase
- Observational
- 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 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: physiological nonlaboring term singleton pregnancies
Who may be able to join
- nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation)
Who cannot join
- fetal malformations, stillbirths, preterm deliveries
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
Naples, Italia, 80138
Marco La Verde, MD, 3389412266, dr.marcolaverde@gmail.com
About this study
Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography.
Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
- Conditions
- Fetal Movement
- Being tested
- ; Computerized cardiotocography (cCTG)
- Keywords
- Fetal movement, Fetal activity, fetal assessment, fetal well-being, Computerized cardiotocography (cCTG), Fetal heart rate (FHR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
; Computerized cardiotocography (cCTG)Diagnostic test
To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
Measured: External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Apr 2019
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MovementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco La Verde, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397874
- Sponsor's protocol ID
- 003
- Status last verified
- Mar 2024
- First submitted
- 18 May 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Perception of Fetal Movements Evaluation Using and Analyzing the Variables of Antepartum Computerized Cardiotocography: An Exploratory Study.
- ClinicalTrials.gov ID
- NCT04397874
- Acronym / sponsor ID
- 003
- Conditions
- Fetal Movement
- Keywords
- Fetal movement, Fetal activity, fetal assessment, fetal well-being, Computerized cardiotocography (cCTG), Fetal heart rate (FHR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 May 2020 (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.
Several studies analysed the association of fetal movement counting with perinatal mortality and fetal outcomes. However, no one examined the relationship of the maternal perception of fetal movement with the fetal wellbeing quantifies through computerised cardiotocography.
Our study evaluates the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- physiological nonlaboring term singleton pregnancies
Key inclusion criteria (1 listed)
- nonlaboring term singleton pregnancies (37 0/7 - 41 6/7 weeks of gestation)
Key exclusion criteria (1 listed)
- fetal malformations, stillbirths, preterm deliveries
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 cardiotocography (cCTG)To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters. | Diagnostic test | – |
Primary outcome
To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
Time frame: External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Movement, run by University of Campania Luigi Vanvitelli 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 1 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco La Verde, MD (+393389412266, dr.marcolaverde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters. (time frame: External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR). 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 12 Mar 2024.