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CompletedNCT03962153Updated May 24, 2019

Ultrasonographic Parameters for Fetal Weight Prediction

An observational study in Fetal Growth Abnormality, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-05-24.

Sponsored by University of Campania Luigi Vanvitelli · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.
02

Conditions studied

  • Fetal Growth Abnormality

Keywords

  • fetal growth
  • ultrasonographic parameters
03

In context

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women

Exclusion criteria

Exclusion Criteria:

  • fetal structural and / or chromosomal anomalies
  • multiple pregnancies
  • premature births (gestational age \<37w)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testObstetric Ultrasonography

    Obstetric Ultrasonography

06

What researchers measure

Primary outcomes

  1. biparietal diameter

    Evaluation of biparietal diameter

    Time frame: 9 months

  2. head circumference

    evaluation of head circumference

    Time frame: 9 months

  3. abdominal circumference

    Evaluation of abdominal circumference

    Time frame: 9 months

  4. femur length

    Evaluation of femur length

    Time frame: 9 months

  5. transtentorial diameter

    Evaluation of transtentorial diameter

    Time frame: 9 months

  6. distance between L1-L4 lumbar vertebrae

    Evaluation of distance between L1-L4

    Time frame: 9 months

  7. Fetal Weight

    Evaluation of Fetal Weight

    Time frame: 9 months

07

Study locations

1 site
  • Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"
    Naples, 80138, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03962153
Responsible party
Prof. Pasquale De Franciscis (Associate Professor, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
May 23, 2019
Start date
Jan 1, 2019
Primary completion
Apr 18, 2019
Completion
Apr 18, 2019
Last update
May 24, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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