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

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ClinicalTrials.gov Identifier: NCT03857659
Recruitment Status : Terminated (COVID related termination)
First Posted : February 28, 2019
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE April 5, 2019
Actual Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Number of participants with abnormal fetal growth or amniotic fluid [ Time Frame: From 28 weeks Gestational age (GA) to 36 weeks GA ]
    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 [ Time Frame: From 36 weeks Gestational age (GA) to 38.6 weeks GA ]
    Abnormal fetal growth or amniotic fluid as assessed by formal ultrasound by RDMS
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to 38.6 weeks GA ]
    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 [ Time Frame: From 28 weeks Gestational age (GA) to time of delivery ]
    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. [ Time Frame: From 28 weeks Gestational age (GA) to 36 weeks GA ]
  • Number of participants with composite neonatal morbidity [ Time Frame: at delivery ]
    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 [ Time Frame: labor until delivery (total time is about 1-48 hrs) ]
    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 [ Time Frame: from time of randomization until discharge (total time is about 15 weeks) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care
Official Title  ICMJE Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Fetal Growth Abnormality
  • Amniotic Fluid; Disorder
Intervention  ICMJE
  • Diagnostic Test: Point-of-care ultrasound (POC-US)
    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.
  • Diagnostic Test: Routine antenatal care
    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)
  • Diagnostic Test: Formal ultrasound
    Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
Study Arms  ICMJE
  • Experimental: Point of care ultrasound (POC-US)
    Point of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks
    Interventions:
    • Diagnostic Test: Point-of-care ultrasound (POC-US)
    • Diagnostic Test: Formal ultrasound
  • Active Comparator: Routine antenatal care
    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)
    Interventions:
    • Diagnostic Test: Routine antenatal care
    • Diagnostic Test: Formal ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2020)
113
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2019)
270
Actual Study Completion Date  ICMJE May 20, 2020
Actual Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03857659
Other Study ID Numbers  ICMJE HSC-MS-18-1074
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Bicocca, MD University of Texas Health Science Center of Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP