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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Withdrawn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
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retardation, Fetal Growth focused on measuring Fetal growth restriction, macrosomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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).

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

    First Posted
    June 10, 2015
    Last Updated
    June 28, 2018
    Sponsor
    The University of Texas Health Science Center, Houston
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    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    Withdrawn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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