Prenatal CareNCT05564910
Computerized Cardiotocography and Maternal Coffee Habits
An observational study of Prenatal Care, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Care
- How many people
- 134 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 28 Sep 2022
- How long will I take part?
- 1 Year
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: we included only term pregnant, who performed a computerized cardiotocography before the delivery.
Who may be able to join
- gestationale age >37 weeks
Who cannot join
- fetal malformations,
- stillbirths
- preterm labour
- preterm and term premature rupture of membranes
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
Official title: Computerized Cardiotocography and Fetal Heart Response to Maternal Coffee Intake: A Prospective Study
The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant women before the CTG.
- Conditions
- Prenatal Care
- Keywords
- computerised cardiotocography, Fetal monitoring, nutrition in pregnancy, prenatal care, fetal heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coffe group | Pregnant women who referred caffeine intake. | |
| Control group | Pregnant women without caffeine intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized cardiotocography
Computerized cardiotocography (cCTG) parameters evaluate the fetal heart rate. We analyzed the cCTG between the two groups: pregnant who took coffee and pregnant with no coffee intake.
Measured: 1 day (cardiotocographic's test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jul 2022
- Primary completion30 Aug 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal CareStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
- Target duration
- 1 Year
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
- NCT05564910
- Sponsor's protocol ID
- 0018443/i
- Status last verified
- Oct 2022
- First submitted
- 28 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cardiotocography and Fetal Heart Response to Maternal Coffee Intake: A Prospective Study
- ClinicalTrials.gov ID
- NCT05564910
- Acronym / sponsor ID
- 0018443/i
- Conditions
- Prenatal Care
- Keywords
- computerised cardiotocography, Fetal monitoring, nutrition in pregnancy, prenatal care, fetal heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 4 Oct 2022 (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.
The study includes pregnant women referred for foetal antepartum computerized cardiotocography (cCTG) monitoring as outpatients. Pregnant women were divided into two groups based on their coffee intake: the coffee group and the control group. Each pregnant woman had cCTG. Two doctors assessed and recorded the amount of coffee taken by pregnant women before the CTG.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffe group | – | –Pregnant women who referred caffeine intake. |
| Control group | – | –Pregnant women without caffeine intake. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- we included only term pregnant, who performed a computerized cardiotocography before the delivery.
Key inclusion criteria (1 listed)
- gestationale age >37 weeks
Key exclusion criteria (4 listed)
- fetal malformations,
- stillbirths
- preterm labour
- preterm and term premature rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Computerized cardiotocography
Time frame: 1 day (cardiotocographic's test)
Computerized cardiotocography (cCTG) parameters evaluate the fetal heart rate. We analyzed the cCTG between the two groups: pregnant who took coffee and pregnant with no coffee intake.
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 Oct 2022.
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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 Prenatal Care, 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 4 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 Oct 2022. 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?
Computerized cardiotocography (time frame: 1 day (cardiotocographic's test)). 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 Oct 2022.