Antenatal Development Evaluated Prospectively (ADEPT)
Primary Purpose
Retardation, Fetal Growth, Macrosomia, Fetal
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Customized fetal growth curves
Sponsored by

About this trial
This is an interventional diagnostic trial for Retardation, Fetal Growth focused on measuring Fetal growth restriction, macrosomia
Eligibility Criteria
Inclusion Criteria:
- Gestational age greater than or equal to 24 weeks gestation.
- Maternal age over 18 years,
- Prior normal fetal anatomy ultrasound done at main ultrasound unit
Exclusion Criteria:
1. Pregnancies carrying higher order multiples (triplets, quadruplets, etc).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Population-based
Customized-based
Arm Description
Participants will be randomly assigned to population-based fetal growth curves
Participants will be randomly assigned to customized-based fetal growth curves (intervention)
Outcomes
Primary Outcome Measures
Detection of fetal growth abnormalities
Birth weight will be used to confirm prenatal diagnosis of fetal growth abnormality
Secondary Outcome Measures
Full Information
NCT ID
NCT02478554
First Posted
June 10, 2015
Last Updated
June 28, 2018
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02478554
Brief Title
Antenatal Development Evaluated Prospectively
Acronym
ADEPT
Official Title
Customized Versus Population Fetal Growth Curves: A Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Not IRB approved
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retardation, Fetal Growth, Macrosomia, Fetal
Keywords
Fetal growth restriction, macrosomia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Population-based
Arm Type
No Intervention
Arm Description
Participants will be randomly assigned to population-based fetal growth curves
Arm Title
Customized-based
Arm Type
Active Comparator
Arm Description
Participants will be randomly assigned to customized-based fetal growth curves (intervention)
Intervention Type
Other
Intervention Name(s)
Customized fetal growth curves
Intervention Description
Fetal weight will be plotted against growth curves specific for height, weight, parity and ethnicity
Primary Outcome Measure Information:
Title
Detection of fetal growth abnormalities
Description
Birth weight will be used to confirm prenatal diagnosis of fetal growth abnormality
Time Frame
Participants will be followed from 24 weeks gestation to 2 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Gestational age greater than or equal to 24 weeks gestation.
Maternal age over 18 years,
Prior normal fetal anatomy ultrasound done at main ultrasound unit
Exclusion Criteria:
1. Pregnancies carrying higher order multiples (triplets, quadruplets, etc).
12. IPD Sharing Statement
Learn more about this trial
Antenatal Development Evaluated Prospectively
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