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Antenatal Testing in Obese Woman, is it Really Necessary? (ATOWS)

Primary Purpose

Obesity in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External fetal monitor for Nonstress test
Ultrasonography for Biophysical profile
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity in Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

less then 32 weeks gestation BMI > 30kg/m2 English speaking

Exclusion Criteria:

age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Nonstress test

    Biophysical profile

    Kick counts only

    Arm Description

    Subjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period.

    Subjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of >2cm. The duration of this test is no more than 30 minutes.

    Subjects will monitor fetal kick counts only.

    Outcomes

    Primary Outcome Measures

    Stillbirth
    demise of infant prior to delivery as verified by ultrasonography
    Mode of delivery
    whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded

    Secondary Outcome Measures

    Neonatal intensive care unit admission admission
    Apgar score of less than 7 at 5 minutes

    Full Information

    First Posted
    June 24, 2016
    Last Updated
    June 29, 2016
    Sponsor
    University of Tennessee
    Collaborators
    Regional One Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02821988
    Brief Title
    Antenatal Testing in Obese Woman, is it Really Necessary?
    Acronym
    ATOWS
    Official Title
    Antenatal Testing in Obese Woman, is it Really Necessary?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Tennessee
    Collaborators
    Regional One Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).
    Detailed Description
    Purpose: To determine if antenatal testing improves outcomes in obese pregnant women Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes. Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI >30kg/m2 Research Design: Randomized Controlled Trial Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution. Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs <7 at 5 minutes of life

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity in Pregnancy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nonstress test
    Arm Type
    Experimental
    Arm Description
    Subjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period.
    Arm Title
    Biophysical profile
    Arm Type
    Experimental
    Arm Description
    Subjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of >2cm. The duration of this test is no more than 30 minutes.
    Arm Title
    Kick counts only
    Arm Type
    No Intervention
    Arm Description
    Subjects will monitor fetal kick counts only.
    Intervention Type
    Device
    Intervention Name(s)
    External fetal monitor for Nonstress test
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasonography for Biophysical profile
    Primary Outcome Measure Information:
    Title
    Stillbirth
    Description
    demise of infant prior to delivery as verified by ultrasonography
    Time Frame
    until delivery, up to 41 weeks
    Title
    Mode of delivery
    Description
    whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded
    Time Frame
    at delivery, up to 41 weeks
    Secondary Outcome Measure Information:
    Title
    Neonatal intensive care unit admission admission
    Time Frame
    at delivery, up to 41 weeks
    Title
    Apgar score of less than 7 at 5 minutes
    Time Frame
    at delivery, up to 41 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: less then 32 weeks gestation BMI > 30kg/m2 English speaking Exclusion Criteria: age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura Grese, MD
    Phone
    4235712990
    Email
    lgrese@uthsc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luis Gomez, MD
    Email
    lgomez2@uthsc.edu

    12. IPD Sharing Statement

    Learn more about this trial

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