Antenatal Development Evaluated Prospectively

Macrosomia, Fetal Clinical Trial

— ADEPT  

Official title:

Customized Versus Population Fetal Growth Curves: A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02478554
• Other study ID #: HSC-MS-15-0536
• Status: Withdrawn
• Phase: N/A
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fetal growth abnormalities is one of the most common problems faced in modern obstetrics. The association between low birth weight and perinatal death as well as severe morbidity is well known. Since fetal weight cannot be measured directly, obstetricians use estimates of fetal weight obtained by utilizing various ultrasonographic measurements to diagnose growth abnormalities. Currently in clinical practice, the majority of fetal ultrasound centers employ population-based fetal growth curves that have been previously published and updated to estimate fetal weight percentiles. Up to 70% of neonates found to be below the 10% percentile for estimated fetal weight in population-based growth curves are actually constitutionally small; that is a neonate deemed "small" based on standardized growth curves but in reality have reached its appropriate growth potential in relation to its genetic predisposition.

An equally difficult clinical scenario is fetal macrosomia. A recent meta-analysis revealed that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from 15-79%. When compared with neonates with normal birth weight, the odds ratio of emergency cesarean delivery and shoulder dystocia are increased significantly.

Various ultrasound parameters have been tested in an effort to detect both fetal compromise prior to the development of permanent damage and allow differentiation between true fetal growth abnormalities and normal growth potential. Recent reports have introduced the concept of customized fetal growth curve which uses physiological variables to report an adjusted fetal growth assessment. To date, the use of customized fetal growth curves has not been evaluated prospectively. Furthermore, this strategy has not been compared to standard population-based fetal growth curves currently used in clinical practice to determine which would be the most ideal for use in clinical practice.

The primary research question is: are customized fetal growth curves more accurate than population-based fetal growth curves at predicting abnormalities in fetal growth, defined as small-for-gestational age or large-for-gestational age at birth in newborns of high-risk pregnancies? Randomly, participants will be assigned to either having fetal growth reported by customized or population bases growth curves.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Gestational age greater than or equal to 24 weeks gestation.

2. Maternal age over 18 years,

3. Prior normal fetal anatomy ultrasound done at main ultrasound unit

Exclusion Criteria:

1. Pregnancies carrying higher order multiples (triplets, quadruplets, etc).

Related Conditions & MeSH terms

• Fetal Macrosomia
• Macrosomia, Fetal
• Retardation, Fetal Growth

Intervention

Other:
• Customized fetal growth curves
Fetal weight will be plotted against growth curves specific for height, weight, parity and ethnicity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of fetal growth abnormalities	Birth weight will be used to confirm prenatal diagnosis of fetal growth abnormality	Participants will be followed from 24 weeks gestation to 2 weeks postpartum