Fetal Growth AbnormalityNCT03962153
Ultrasonographic Parameters for Fetal Weight Prediction
An observational study of Fetal Growth Abnormality, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The hypothesis is to increase the predictability of the ultrasound examination evaluating new fetal parameters: in fact the thickness of the soft tissues can contribute significantly to the fetal weight and the characteristics of the thoracic cage may correlate with the fetal weight. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Growth Abnormality
- What is being tested?
- Obstetric Ultrasonography
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 18 Apr 2019
- 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 45 years
- Women only
- Adult
Study population: single pregnancies, free of complications, with delivery completed between 37 and 42 weeks, but within a week of the last ultrasound examination performed. Patients are selected among those candidates with elective caesarean section, pregnant who come to hospital for prodroma of labor and conditions that require induction of childbirth such as prolonged pregnancy or PROM.
Who may be able to join
- pregnant women
Who cannot join
- fetal structural and / or chromosomal anomalies
- multiple pregnancies
- premature births (gestational age <37w)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
Naples, 80138
About this study
Official title: New Ultrasonographic Parameters for Fetal Weight Prediction
The hypothesis is to increase the predictability of the ultrasound examination evaluating new fetal parameters: in fact the thickness of the soft tissues can contribute significantly to the fetal weight and the characteristics of the thoracic cage may correlate with the fetal weight.
Read the detailed description
Estimation of fetal weight (EFW: Estimated Fetal Weight) with ultrasound examination is a common practice in obstetrics and is important for planning the mode and timing of birth, especially in pregnancies at risk for altered fetal growth.
The conditions most commonly associated with impaired fetal growth are:
- IUGR: in these cases the ultrasound estimate of fetal weight is fundamental to decide the timing of delivery, since the neonatal outcome correlates positively with the fetal weight as well as with the flowmetry parameters
- fetal macrosomia (fetal weight greater than 4500 g) associated or not with gestational diabetes: in such cases an accurate estimation of the fetal weight is necessary and careful evaluation of any fetal-pelvic disproportion to decide both the timing of the birth that can be anticipated compared to at the physiological end of pregnancy is the mode of birth, vaginal or laparotomic in the event of a pelvic fetus disproportion.
In the 1970s the estimate of fetal weight was based on the measurement of the symphysis-fundus uterine distance (SFH) for which:
- SFH <33 cm: predictive of a fetal weight <3100 gr
- SFH> 34 cm: predictive of a fetal weight = o> 4000 gr.
At present, the fetal weight estimate is performed with biometric ultrasound parameters:
- DBP: biparietal diameter
- HC: head circumference
- AC: abdominal circumference
- FL: femur length There are standardized tables of variation of these parameters according to the gestational epoch for which the knowledge of the correct gestational epoch is fundamental for the correct interpretation of the data.
The fetal weight is calculated using mathematical formulas automatically obtained from ultrasound equipment of which the most used:
- Shepard's formula as a function of BPD and AC.
- formula of Campbell and Wilkin: it is in function of the abdominal circumference
- Hadlock formula: use the combination of different biometric parameters (BPD-HC-AC-FL).
Even if the guidelines provide for three ultrasound examinations for physiological pregnancies (one for each trimester of pregnancy), it is common practice to evaluate the biometric ultrasound parameters at the end of pregnancy and in any case when the patient is admitted for the delivery. It is obvious that in this time of pregnancy a closer correlation between biometric parameters and fetal weight is observed.
The problems related to the ultrasound estimation of fetal weight are represented by:
- significant intra-operator variability
- reduced accuracy for extremes of fetal weight (small or macrosomic fetuses)
- about 10% discrepancy between estimated fetal weight on an echographic basis according to Hadlock and actual weight of the newborn at birth.
- Conditions
- Fetal Growth Abnormality
- Being tested
- Obstetric Ultrasonography
- Keywords
- fetal growth, ultrasonographic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric UltrasonographyDiagnostic test
Obstetric Ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
biparietal diameter
Evaluation of biparietal diameter
Measured: 9 months
head circumference
evaluation of head circumference
Measured: 9 months
abdominal circumference
Evaluation of abdominal circumference
Measured: 9 months
femur length
Evaluation of femur length
Measured: 9 months
transtentorial diameter
Evaluation of transtentorial diameter
Measured: 9 months
distance between L1-L4 lumbar vertebrae
Evaluation of distance between L1-L4
Measured: 9 months
Fetal Weight
Evaluation of Fetal Weight
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 Jan 2019
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth AbnormalityStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Pasquale De Franciscis, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962153
- Sponsor's protocol ID
- N.603
- Status last verified
- May 2019
- First submitted
- 21 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Ultrasonographic Parameters for Fetal Weight Prediction
- ClinicalTrials.gov ID
- NCT03962153
- Acronym / sponsor ID
- N.603
- Conditions
- Fetal Growth Abnormality
- Keywords
- fetal growth, ultrasonographic parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 23 May 2019 (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 hypothesis is to increase the predictability of the ultrasound examination evaluating new fetal parameters: in fact the thickness of the soft tissues can contribute significantly to the fetal weight and the characteristics of the thoracic cage may correlate with the fetal weight.
Detailed description
Estimation of fetal weight (EFW: Estimated Fetal Weight) with ultrasound examination is a common practice in obstetrics and is important for planning the mode and timing of birth, especially in pregnancies at risk for altered fetal growth.
The conditions most commonly associated with impaired fetal growth are:
- IUGR: in these cases the ultrasound estimate of fetal weight is fundamental to decide the timing of delivery, since the neonatal outcome correlates positively with the fetal weight as well as with the flowmetry parameters
- fetal macrosomia (fetal weight greater than 4500 g) associated or not with gestational diabetes: in such cases an accurate estimation of the fetal weight is necessary and careful evaluation of any fetal-pelvic disproportion to decide both the timing of the birth that can be anticipated compared to at the physiological end of pregnancy is the mode of birth, vaginal or laparotomic in the event of a pelvic fetus disproportion.
In the 1970s the estimate of fetal weight was based on the measurement of the symphysis-fundus uterine distance (SFH) for which:
- SFH <33 cm: predictive of a fetal weight <3100 gr
- SFH> 34 cm: predictive of a fetal weight = o> 4000 gr.
At present, the fetal weight estimate is performed with biometric ultrasound parameters:
- DBP: biparietal diameter
- HC: head circumference
- AC: abdominal circumference
- FL: femur length There are standardized tables of variation of these parameters according to the gestational epoch for which the knowledge of the correct gestational epoch is fundamental for the correct interpretation of the data.
The fetal weight is calculated using mathematical formulas automatically obtained from ultrasound equipment of which the most used:
- Shepard's formula as a function of BPD and AC.
- formula of Campbell and Wilkin: it is in function of the abdominal circumference
- Hadlock formula: use the combination of different biometric parameters (BPD-HC-AC-FL).
Even if the guidelines provide for three ultrasound examinations for physiological pregnancies (one for each trimester of pregnancy), it is common practice to evaluate the biometric ultrasound parameters at the end of pregnancy and in any case when the patient is admitted for the delivery. It is obvious that in this time of pregnancy a closer correlation between biometric parameters and fetal weight is observed.
The problems related to the ultrasound estimation of fetal weight are represented by:
- significant intra-operator variability
- reduced accuracy for extremes of fetal weight (small or macrosomic fetuses)
- about 10% discrepancy between estimated fetal weight on an echographic basis according to Hadlock and actual weight of the newborn at birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- single pregnancies, free of complications, with delivery completed between 37 and 42 weeks, but within a week of the last ultrasound examination performed. Patients are selected among those candidates with elective caesarean section, pregnant who come to hospital for prodroma of labor and conditions that require induction of childbirth such as prolonged pregnancy or PROM.
Key inclusion criteria (1 listed)
- pregnant women
Key exclusion criteria (3 listed)
- fetal structural and / or chromosomal anomalies
- multiple pregnancies
- premature births (gestational age <37w)
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 |
|---|---|---|
| Obstetric UltrasonographyObstetric Ultrasonography | Diagnostic test | – |
Primary outcome
biparietal diameter
Time frame: 9 months
Evaluation of biparietal diameter
head circumference
Time frame: 9 months
evaluation of head circumference
abdominal circumference
Time frame: 9 months
Evaluation of abdominal circumference
femur length
Time frame: 9 months
Evaluation of femur length
transtentorial diameter
Time frame: 9 months
Evaluation of transtentorial diameter
distance between L1-L4 lumbar vertebrae
Time frame: 9 months
Evaluation of distance between L1-L4
Fetal Weight
Time frame: 9 months
Evaluation of Fetal Weight
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 24 May 2019.
- Individual participant dataSharing planned: No
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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 Growth Abnormality, 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 3 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 24 May 2019. 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?
biparietal diameter (time frame: 9 months). The study lists 7 primary outcomes in all. 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 24 May 2019.