Fetal ConditionsNCT04366076
Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?
An observational study of Fetal Conditions and Fetal Movement Disorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum 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 Conditions, Fetal Movement Disorder
- What is being tested?
- Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 20 Apr 2020
- 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 (>37 weeks) without maternal or fetal complication
Who may be able to join
- physiological nonlaboring term singleton pregnancies
Who cannot join
- . Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
Naples, Italia, 80138
About this study
BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography.
OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
- Conditions
- Fetal Conditions, Fetal Movement Disorder
- Being tested
- Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum
- Keywords
- Fetal hiccups, fetal movement, computerised cardiotocography, cardiotocography, computerized analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartumDiagnostic test
The investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus
| Study group | Role | What they receive |
|---|---|---|
| nonlaboring term singleton pregnancies | A total of 51 nonlaboring term singleton pregnancies were enrolled. Receives: Diagnostic Test: Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
antepartum computerised cardiotocography parameters are the baseline fetal heart rate (Basal FHR), accelerations and decelerations, long-term FHR variation (LTV), short-term FHR variation (STV), episodes of high/low FHR variation and number of fetal movements for an hour (FM)
Measured: pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2019
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal ConditionsStudies 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
- 55 participants (actual)
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
- NCT04366076
- Sponsor's protocol ID
- 002
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 4 May 2020
- 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 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?
- ClinicalTrials.gov ID
- NCT04366076
- Acronym / sponsor ID
- 002
- Conditions
- Fetal Conditions, Fetal Movement Disorder
- Keywords
- Fetal hiccups, fetal movement, computerised cardiotocography, cardiotocography, computerized analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 28 Apr 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.
BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography.
OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonlaboring term singleton pregnancies | – | Diagnostic Test: Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartumA total of 51 nonlaboring term singleton pregnancies were enrolled. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- physiological nonlaboring term singleton pregnancies (>37 weeks) without maternal or fetal complication
Key inclusion criteria (1 listed)
- physiological nonlaboring term singleton pregnancies
Key exclusion criteria (1 listed)
- . Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.
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 |
|---|---|---|
| Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartumThe investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus | Diagnostic test | nonlaboring term singleton pregnancies |
Primary outcome
The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.
Time frame: pre-intervention
antepartum computerised cardiotocography parameters are the baseline fetal heart rate (Basal FHR), accelerations and decelerations, long-term FHR variation (LTV), short-term FHR variation (STV), episodes of high/low FHR variation and number of fetal movements for an hour (FM)
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 4 May 2020.
- 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.
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?
An observational study of Fetal Conditions and Fetal Movement Disorder, 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: finished, as of the sponsor's last update on 4 May 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?
The primary outcome was the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies. (time frame: pre-intervention). 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 4 May 2020.