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Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care (STAR)

Primary Purpose

Fetal Growth Abnormality, Amniotic Fluid; Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-care ultrasound (POC-US)
Routine antenatal care
Formal ultrasound
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 Fetal Growth Abnormality focused on measuring Pregnancy, Ultrasound, neonatal morbidity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Maternal age of 18 at the time of consent
  • Singleton gestation
  • Ultrasound examination that confirms or revises the estimated date of delivery (EDD) before 22 0/7 weeks of gestational age
  • Gestational age ≥ 24 weeks gestation

Exclusion Criteria:

  • Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT)
  • Fetal chromosomal or genetic abnormalities
  • Fetal malformations or soft markers identified on fetal anatomy survey
  • Current pregnancy is a result of in vitro fertilization
  • Documented uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criterion.
  • Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelphus uterus), abnormal placentation (placenta previa, accrete, percreta), uterine fibroids.
  • Cerclage in the current pregnancy
  • History of intrauterine fetal demise
  • Fetal isoimmunization or alloimmunization

  • History of medical complications such as:

    • Cancer (including melanoma but excluding other skin cancers)
    • Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).
    • Renal disease with altered renal function (creatinine > 0.9 or proteinuria)
    • Epilepsy or other seizure disorder
    • Any collagen disease (lupus erythematosus, scleroderma, etc.)
    • Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
    • Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb > 9 gm/dl). Patients with sickle cell disease are excluded.
    • Chronic pulmonary disease including asthma requiring regular use of medication and active tuberculosis (TB). An asthma inhaler used on an as needed basis (PRN) for a cold or an asthma attack is not considered regular use.
    • Heart disease except mitral value prolapse not requiring medication
    • Cardiovascular disorders: chronic hypertension
    • Liver disorders accounting for cholestasis
    • Infectious diseases: HIV, Cytomegalovirus (CMV), toxoplasmosis, parvovirus B19

Sites / Locations

  • University of Texas Health Science Center of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Point of care ultrasound (POC-US)

Routine antenatal care

Arm Description

Point of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks

Routine care with fundal height measurement at each antenatal appointment every 2 weeks from 28-36 weeks. As well as clinically indicated obstetric ultrasound by a Registered Diagnostic Medical Sonographer (RDMS)

Outcomes

Primary Outcome Measures

Number of participants with abnormal fetal growth or amniotic fluid
Abnormal fetal growth or amniotic fluid as assessed by clinical evaluation of uterine size by SFH versus POC-US evaluation.
Number of participants with abnormal fetal growth or amniotic fluid
Abnormal fetal growth or amniotic fluid as assessed by formal ultrasound by RDMS

Secondary Outcome Measures

Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Sensitivity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Specificity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Specificity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Positive predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Positive predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Negative predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Negative predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
False positive rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
False positive rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
False negative rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
False negative rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Positive likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Positive likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Negative likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Negative likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Number of referrals for formal USE.
Number of participants with composite neonatal morbidity
Composite neonatal morbidity is defined as any of the following: 1) Apgar score < 3 at 5 min, 2) birth trauma, 3) hypotension requiring vasopressor support, 4) hypoxic-ischemic encephalopathy, 5) infection, 6) intracranial or subgaleal hemorrhage, 7) meconium aspiration syndrome, 8) perinatal death, 9) respiratory support, or 10) seizure. 4. The rate of composite neonatal morbidity, including any of the following: 1) Apgar score < 3 at 5 min, 2) birth trauma, 3) hypotension requiring vasopressor support, 4) hypoxic-ischemic encephalopathy, 5) infection, 6) intracranial or subgaleal hemorrhage, 7) meconium aspiration syndrome, 8) perinatal death, 9) respiratory support, or 10) seizure.
Number of participants with composite maternal morbidity
Composite maternal morbidity is defined as any of the following: o 1) chorioamnionitis, 2) cesarean delivery in labor, 3) wound infection, 4) transfusion, 5) deep venous thrombus or pulmonary embolism, 6) admission to intensive care unit, 7) postpartum hemorrhage, or 8) death
Total costs of care from the health system perspective
6. The total costs of care from the health system perspective during the study period (from the date of enrollment through the mothers' post-delivery discharge and the infants' post-birth discharge). The hospital costs (for ER visits, admissions, delivery, and neonatal care) will be obtained from the Memorial Hermann Hospital cost-accounting system. The costs of physician services received during the study period by the mothers and the newborns will be estimated using relative value units (RVUs) based on claims data. The intervention arm will be augmented by the cost of the POC-US examinations. The POC-US costs will include the costs of the POC provider time (estimated based on limited time-motion studies, salary, and fringe data) and the depreciation costs of the portable ultrasound equipment.

Full Information

First Posted
February 26, 2019
Last Updated
June 2, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03857659
Brief Title
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care
Acronym
STAR
Official Title
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID related termination
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
May 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study us to compare the rate of prenatal identification of abnormal fetal growth or amniotic fluid between clinical evaluation of uterine size by symphysis fundal height (SFH) measurements versus point-of-care ultrasound (POC-US) evaluation of abdominal circumference (AC) and maximum vertical pocket (MVP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Abnormality, Amniotic Fluid; Disorder
Keywords
Pregnancy, Ultrasound, neonatal morbidity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Point of care ultrasound (POC-US)
Arm Type
Experimental
Arm Description
Point of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks
Arm Title
Routine antenatal care
Arm Type
Active Comparator
Arm Description
Routine care with fundal height measurement at each antenatal appointment every 2 weeks from 28-36 weeks. As well as clinically indicated obstetric ultrasound by a Registered Diagnostic Medical Sonographer (RDMS)
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-care ultrasound (POC-US)
Intervention Description
POC-US evaluation will be conducted using the portable ultrasound machine, which is capable of straight-line measurements for assessment of the amniotic fluid, as well as ellipse measurements for determination of abdominal circumference. POC-US evaluation will be conducted every 4 weeks from 28-36 weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
Routine antenatal care
Intervention Description
Routine care with fundal height measurement at each antenatal appointment every 2 weeks from 28-36 weeks. As well as clinically indicated obstetric ultrasound by a Registered Diagnostic Medical Sonographer (RDMS)
Intervention Type
Diagnostic Test
Intervention Name(s)
Formal ultrasound
Intervention Description
Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
Primary Outcome Measure Information:
Title
Number of participants with abnormal fetal growth or amniotic fluid
Description
Abnormal fetal growth or amniotic fluid as assessed by clinical evaluation of uterine size by SFH versus POC-US evaluation.
Time Frame
From 28 weeks Gestational age (GA) to 36 weeks GA
Title
Number of participants with abnormal fetal growth or amniotic fluid
Description
Abnormal fetal growth or amniotic fluid as assessed by formal ultrasound by RDMS
Time Frame
From 36 weeks Gestational age (GA) to 38.6 weeks GA
Secondary Outcome Measure Information:
Title
Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Sensitivity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Specificity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Specificity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Positive predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Positive predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Negative predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Negative predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
False positive rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
False positive rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
False negative rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
False negative rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Positive likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Positive likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Negative likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
Description
Test performance characteristics of SFH measurements and POC US for identification of abnormal fetal growth or amniotic fluid using formal USE as the diagnostic standard.
Time Frame
From 28 weeks Gestational age (GA) to 38.6 weeks GA
Title
Negative likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
Description
Test performance characteristics of SFH measurements and POC US for identification of birthweight < 10th percentile or > 90th percentile using the neonates' gestational age at delivery as the standard
Time Frame
From 28 weeks Gestational age (GA) to time of delivery
Title
Number of referrals for formal USE.
Time Frame
From 28 weeks Gestational age (GA) to 36 weeks GA
Title
Number of participants with composite neonatal morbidity
Description
Composite neonatal morbidity is defined as any of the following: 1) Apgar score < 3 at 5 min, 2) birth trauma, 3) hypotension requiring vasopressor support, 4) hypoxic-ischemic encephalopathy, 5) infection, 6) intracranial or subgaleal hemorrhage, 7) meconium aspiration syndrome, 8) perinatal death, 9) respiratory support, or 10) seizure. 4. The rate of composite neonatal morbidity, including any of the following: 1) Apgar score < 3 at 5 min, 2) birth trauma, 3) hypotension requiring vasopressor support, 4) hypoxic-ischemic encephalopathy, 5) infection, 6) intracranial or subgaleal hemorrhage, 7) meconium aspiration syndrome, 8) perinatal death, 9) respiratory support, or 10) seizure.
Time Frame
at delivery
Title
Number of participants with composite maternal morbidity
Description
Composite maternal morbidity is defined as any of the following: o 1) chorioamnionitis, 2) cesarean delivery in labor, 3) wound infection, 4) transfusion, 5) deep venous thrombus or pulmonary embolism, 6) admission to intensive care unit, 7) postpartum hemorrhage, or 8) death
Time Frame
labor until delivery (total time is about 1-48 hrs)
Title
Total costs of care from the health system perspective
Description
6. The total costs of care from the health system perspective during the study period (from the date of enrollment through the mothers' post-delivery discharge and the infants' post-birth discharge). The hospital costs (for ER visits, admissions, delivery, and neonatal care) will be obtained from the Memorial Hermann Hospital cost-accounting system. The costs of physician services received during the study period by the mothers and the newborns will be estimated using relative value units (RVUs) based on claims data. The intervention arm will be augmented by the cost of the POC-US examinations. The POC-US costs will include the costs of the POC provider time (estimated based on limited time-motion studies, salary, and fringe data) and the depreciation costs of the portable ultrasound equipment.
Time Frame
from time of randomization until discharge (total time is about 15 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Maternal age of 18 at the time of consent Singleton gestation Ultrasound examination that confirms or revises the estimated date of delivery (EDD) before 22 0/7 weeks of gestational age Gestational age ≥ 24 weeks gestation Exclusion Criteria: Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) Fetal chromosomal or genetic abnormalities Fetal malformations or soft markers identified on fetal anatomy survey Current pregnancy is a result of in vitro fertilization Documented uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criterion. Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelphus uterus), abnormal placentation (placenta previa, accrete, percreta), uterine fibroids. Cerclage in the current pregnancy History of intrauterine fetal demise Fetal isoimmunization or alloimmunization History of medical complications such as: Cancer (including melanoma but excluding other skin cancers) Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational). Renal disease with altered renal function (creatinine > 0.9 or proteinuria) Epilepsy or other seizure disorder Any collagen disease (lupus erythematosus, scleroderma, etc.) Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes) Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb > 9 gm/dl). Patients with sickle cell disease are excluded. Chronic pulmonary disease including asthma requiring regular use of medication and active tuberculosis (TB). An asthma inhaler used on an as needed basis (PRN) for a cold or an asthma attack is not considered regular use. Heart disease except mitral value prolapse not requiring medication Cardiovascular disorders: chronic hypertension Liver disorders accounting for cholestasis Infectious diseases: HIV, Cytomegalovirus (CMV), toxoplasmosis, parvovirus B19
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Bicocca, MD
Organizational Affiliation
University of Texas Health Science Center of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care

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