Ultrasonographic Parameters for Fetal Weight Prediction

Fetal Growth Abnormality Clinical Trial

Official title:

New Ultrasonographic Parameters for Fetal Weight Prediction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962153
• Other study ID #: N.603
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 18, 2019

Study information

• Verified date: May 2019
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 18, 2019
• Est. primary completion date: April 18, 2019
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women

Exclusion Criteria:

• fetal structural and / or chromosomal anomalies

• multiple pregnancies

• premature births (gestational age <37w)

Related Conditions & MeSH terms

• Fetal Growth Abnormality
• Fetal Weight

Intervention

Diagnostic Test:
• Obstetric Ultrasonography
Obstetric Ultrasonography

Locations

Country	Name	City	State
Italy	Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli"	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biparietal diameter	Evaluation of biparietal diameter	9 months
Primary	head circumference	evaluation of head circumference	9 months
Primary	abdominal circumference	Evaluation of abdominal circumference	9 months
Primary	femur length	Evaluation of femur length	9 months
Primary	transtentorial diameter	Evaluation of transtentorial diameter	9 months
Primary	distance between L1-L4 lumbar vertebrae	Evaluation of distance between L1-L4	9 months
Primary	Fetal Weight	Evaluation of Fetal Weight	9 months