Skip to main content
OpenTrials
Completed

NCT Number: NCT03962153

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"

Naples, 80138, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women

Exclusion criteria

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

Treatment and study plan

Obstetric Ultrasonography

Diagnostic Test

Obstetric Ultrasonography

Primary outcomes

  1. biparietal diameter

    Time frame: 9 months

    Evaluation of biparietal diameter

  2. head circumference

    Time frame: 9 months

    evaluation of head circumference

  3. abdominal circumference

    Time frame: 9 months

    Evaluation of abdominal circumference

  4. femur length

    Time frame: 9 months

    Evaluation of femur length

  5. transtentorial diameter

    Time frame: 9 months

    Evaluation of transtentorial diameter

  6. distance between L1-L4 lumbar vertebrae

    Time frame: 9 months

    Evaluation of distance between L1-L4

  7. Fetal Weight

    Time frame: 9 months

    Evaluation of Fetal Weight

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

New Ultrasonographic Parameters for Fetal Weight Prediction

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 23, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.