Fetal HypoxiaNCT04364308
The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries
An observational study of Fetal Hypoxia and Fetal Conditions, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal and neonatal acidemia can be utilised as predictors for establishing such risk. Several researches have reported a marked relation between low values of fetal pH with short- and long-term adverse neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Hypoxia, Fetal Conditions
- What is being tested?
- Fetal Echography
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 1 Sep 2024
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: the investigators enrolled only low-risk pregnant women
Who may be able to join
- singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries
Who cannot join
- Pregnancies complicated by fetal malformations, stillbirth, preterm deliveries.
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
Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal and neonatal acidemia can be utilised as predictors for establishing such risk. Several researches have reported a marked relation between low values of fetal pH with short- and long-term adverse neonatal outcomes. Umbilical cord blood gas studies (UCGS) are considered critical data that gives an objective and certified evaluation of the oxygenation and metabolic status of the fetus. Before birth, the physician can evaluate fetal wellness through cardiotocography and prenatal ultrasound. Other studies had examined the role of fetal Doppler indices before birth and proposed that fetuses with lower impedance in the middle cerebral artery (MCA) or low cerebroplacental ratio (CPR) are at increased risk of adverse pregnancy outcome. However, no research has ever evaluated the possibility of a correlation between ultrasonographic fetal evaluation and fetal umbilical cord pH as a predictor of pre-delivery fetal pH.
The goal of our study was to discovered a potential association between the venous umbilical ph cord blood at delivery and the ultrasonographic feto-maternal doppler indices in patients with a scheduled nonlaboring term singleton caesarean deliveries (SCD), this research is a novel finding.
Read the detailed description
the investigators included in our study only singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries.
This was an observational study carried out at a single university tertiary care center
For every patient, an ultrasound examination was performed within one day of delivery and the fetal doppler indices were recorded. The umbilical venous pH were obtained immediately after delivery and before placental detachment with heparinized syringes
The primary endpoints were CPR, umbilical (UA) and fetal MCA arteries indices. The second endpoints analysed when measurable were ductus venosus (DV) and uterine artery (Ut) pulsatility indices, all indices were examined using colour Doppler ultrasound according to a standard procedure and CPR was evaluated as the ratio between the MCA and UA pulsatility indices.
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters, calculating the correlation coefficient r2 and P-value. Statistical significance was fixed at P<0.05. the investigators performed a linear regression analysis to find the association between the different ultrasound indices and the venous pH.
- Conditions
- Fetal Hypoxia, Fetal Conditions
- Being tested
- Fetal Echography
- Keywords
- Fetal Doppler, Ultrasound exam, cesarean delivery, umbilical cord ph, scheduled cesarean delivery, cerebroplacental ratio
- Medical subject headings
- Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal EchographyOther
Fetal ultrasound and its parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters
the investigators recordered venous umbilical cord pH and all fetal doppler parameters
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 completion19 Apr 2020
- Study completion1 Sep 2024 (estimated)
Why it stopped: No found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies 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
- 100 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
- NCT04364308
- Sponsor's protocol ID
- 358
- Status last verified
- Nov 2023
- First submitted
- 19 Apr 2020
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries
- ClinicalTrials.gov ID
- NCT04364308
- Acronym / sponsor ID
- 358
- Conditions
- Fetal Hypoxia, Fetal Conditions
- Keywords
- Fetal Doppler, Ultrasound exam, cesarean delivery, umbilical cord ph, scheduled cesarean delivery, cerebroplacental ratio
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: No found.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 1 Sep 2024 (estimated)
- 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.
Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal and neonatal acidemia can be utilised as predictors for establishing such risk. Several researches have reported a marked relation between low values of fetal pH with short- and long-term adverse neonatal outcomes. Umbilical cord blood gas studies (UCGS) are considered critical data that gives an objective and certified evaluation of the oxygenation and metabolic status of the fetus. Before birth, the physician can evaluate fetal wellness through cardiotocography and prenatal ultrasound. Other studies had examined the role of fetal Doppler indices before birth and proposed that fetuses with lower impedance in the middle cerebral artery (MCA) or low cerebroplacental ratio (CPR) are at increased risk of adverse pregnancy outcome. However, no research has ever evaluated the possibility of a correlation between ultrasonographic fetal evaluation and fetal umbilical cord pH as a predictor of pre-delivery fetal pH.
The goal of our study was to discovered a potential association between the venous umbilical ph cord blood at delivery and the ultrasonographic feto-maternal doppler indices in patients with a scheduled nonlaboring term singleton caesarean deliveries (SCD), this research is a novel finding.
Detailed description
the investigators included in our study only singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries.
This was an observational study carried out at a single university tertiary care center
For every patient, an ultrasound examination was performed within one day of delivery and the fetal doppler indices were recorded. The umbilical venous pH were obtained immediately after delivery and before placental detachment with heparinized syringes
The primary endpoints were CPR, umbilical (UA) and fetal MCA arteries indices. The second endpoints analysed when measurable were ductus venosus (DV) and uterine artery (Ut) pulsatility indices, all indices were examined using colour Doppler ultrasound according to a standard procedure and CPR was evaluated as the ratio between the MCA and UA pulsatility indices.
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters, calculating the correlation coefficient r2 and P-value. Statistical significance was fixed at P<0.05. the investigators performed a linear regression analysis to find the association between the different ultrasound indices and the venous pH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- the investigators enrolled only low-risk pregnant women
Key inclusion criteria (1 listed)
- singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries
Key exclusion criteria (1 listed)
- Pregnancies complicated by fetal malformations, stillbirth, 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 |
|---|---|---|
| Fetal EchographyFetal ultrasound and its parameters | Other | – |
Primary outcome
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters
Time frame: pre-intervention
the investigators recordered venous umbilical cord pH and all fetal doppler parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- 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 Hypoxia and Fetal Conditions, 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: paused, as of the sponsor's last update on 29 Nov 2023. 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?
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 venous umbilical cord pH at birth was correlated with ultrasound doppler parameters (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 29 Nov 2023.