- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03857659
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care (STAR)
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center of Houston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
|
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)
|
Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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From 28 weeks Gestational age (GA) to 36 weeks GA
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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
|
From 36 weeks Gestational age (GA) to 38.6 weeks GA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
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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
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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.
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From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
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.
|
From 28 weeks Gestational age (GA) to 38.6 weeks GA
|
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
|
From 28 weeks Gestational age (GA) to time of delivery
|
Number of referrals for formal USE.
Time Frame: From 28 weeks Gestational age (GA) to 36 weeks GA
|
From 28 weeks Gestational age (GA) to 36 weeks GA
|
|
Number of participants with composite neonatal morbidity
Time Frame: at delivery
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Composite neonatal morbidity is defined as any of the following:
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at delivery
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Number of participants with composite maternal morbidity
Time Frame: labor until delivery (total time is about 1-48 hrs)
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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 |
labor until delivery (total time is about 1-48 hrs)
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Total costs of care from the health system perspective
Time Frame: from time of randomization until discharge (total time is about 15 weeks)
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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.
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from time of randomization until discharge (total time is about 15 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Matthew Bicocca, MD, University of Texas Health Science Center of Houston
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-18-1074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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