Braxton Hicks' ContractionsNCT04417296
IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
An observational study of Braxton Hicks' Contractions, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Several types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Braxton Hicks' Contractions
- What is being tested?
- antepartum computerised cardiotocography analysis
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 14 Aug 2021
- 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
- No healthy volunteers
- Adult
Study population: We included pregnant who were referred for the fetal antepartum cardiotocography monitoring to the outpatient clinic of the "Luigi Vanvitelli" University of Campania in Naples, Italy. All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"
Who may be able to join
- Nonlaboring women with a term uncomplicated singleton pregnancy
Who cannot join
- complicated singleton pregnancy
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
Several types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Our study wants to estimate the correlation between the maternal perception of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.
- Conditions
- Braxton Hicks' Contractions
- Being tested
- antepartum computerised cardiotocography analysis
- Keywords
- Braxton Hicks' contractions, uterine contractions, fetal well-being, Computerized cardiotocography (cCTG), Fetal heart rate (FHR), Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antepartum computerised cardiotocography analysisDiagnostic test
A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)
| Study group | Role | What they receive |
|---|---|---|
| nonlaboring term singleton pregnancies | All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications" Receives: Diagnostic Test: antepartum computerised cardiotocography analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity
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
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 posted4 Jun 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Braxton Hicks' ContractionsStudies 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
- 49 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
- NCT04417296
- Sponsor's protocol ID
- 004
- Status last verified
- May 2022
- First submitted
- 1 Jun 2020
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
- ClinicalTrials.gov ID
- NCT04417296
- Acronym / sponsor ID
- 004
- Conditions
- Braxton Hicks' Contractions
- Keywords
- Braxton Hicks' contractions, uterine contractions, fetal well-being, Computerized cardiotocography (cCTG), Fetal heart rate (FHR), Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 4 Jun 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 types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Our study wants to estimate the correlation between the maternal perception of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonlaboring term singleton pregnancies | – | Diagnostic Test: antepartum computerised cardiotocography analysisAll patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications" |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We included pregnant who were referred for the fetal antepartum cardiotocography monitoring to the outpatient clinic of the "Luigi Vanvitelli" University of Campania in Naples, Italy. All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"
Key inclusion criteria (1 listed)
- Nonlaboring women with a term uncomplicated singleton pregnancy
Key exclusion criteria (1 listed)
- complicated singleton pregnancy
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 |
|---|---|---|
| antepartum computerised cardiotocography analysisA common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG) | Diagnostic test | nonlaboring term singleton pregnancies |
Primary outcome
the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity
Time frame: pre-intervention
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
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 5 May 2022.
- Individual participant dataSharing planned: Undecided
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 Braxton Hicks' Contractions, 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 5 May 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?
the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity (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 5 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.