Fetal Growth AbnormalitySTARNCT03857659
Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care
A study testing Point-of-care ultrasound (POC-US), Routine antenatal care and Formal ultrasound in people with Fetal Growth Abnormality and Amniotic Fluid; Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Growth Abnormality, Amniotic Fluid; Disorder
- What is being tested?
- Point-of-care ultrasound (POC-US), Routine antenatal care and Formal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center of Houston
Houston, Texas, 77030
About this study
Official title: Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
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).
- Conditions
- Fetal Growth Abnormality, Amniotic Fluid; Disorder
- Being tested
- Point-of-care ultrasound (POC-US), Routine antenatal care, Formal ultrasound
- Keywords
- Pregnancy, Ultrasound, neonatal morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound (POC-US)Diagnostic test
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.
Routine antenatal careDiagnostic test
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 ultrasoundDiagnostic test
Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
| Study group | Role | What they receive |
|---|---|---|
| Point of care ultrasound (POC-US) | Experimental | Point of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks Receives: Diagnostic Test: Point-of-care ultrasound (POC-US); Diagnostic Test: Formal ultrasound |
| Routine antenatal care | Active comparator | 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) Receives: Diagnostic Test: Routine antenatal care; Diagnostic Test: Formal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 28 weeks Gestational age (GA) to 36 weeks GA
Number of participants with abnormal fetal growth or amniotic fluid
Abnormal fetal growth or amniotic fluid as assessed by formal ultrasound by RDMS
Measured: From 36 weeks Gestational age (GA) to 38.6 weeks GA
Secondary outcomes (20)
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.
Measured: From 28 weeks Gestational age (GA) to 38.6 weeks GA
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
Measured: From 28 weeks Gestational age (GA) to time of delivery
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.
Measured: From 28 weeks Gestational age (GA) to 38.6 weeks GA
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: From 28 weeks Gestational age (GA) to time of delivery
Number of referrals for formal USE.
Measured: From 28 weeks Gestational age (GA) to 36 weeks GA
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.
- 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.
Measured: at delivery
Number of participants with composite maternal morbidity
Composite maternal morbidity is defined as any of the following:
- 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
Measured: labor until delivery (total time is about 1-48 hrs)
Total costs of care from the health system perspective
- 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.
Measured: from time of randomization until discharge (total time is about 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start5 Apr 2019
- Primary completion20 Mar 2020
- Study completion20 May 2020
Why it stopped: COVID related termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth AbnormalityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Bicocca, MD, Principal investigator, University of Texas Health Science Center of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857659
- Sponsor's protocol ID
- HSC-MS-18-1074
- Acronym
- STAR
- Status last verified
- Jun 2021
- First submitted
- 26 Feb 2019
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
- ClinicalTrials.gov ID
- NCT03857659
- Acronym / sponsor ID
- STAR / HSC-MS-18-1074
- Conditions
- Fetal Growth Abnormality, Amniotic Fluid; Disorder
- Keywords
- Pregnancy, Ultrasound, neonatal morbidity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID related termination
- Enrolment
- 113 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point of care ultrasound (POC-US) | Experimental | Diagnostic Test: Point-of-care ultrasound (POC-US), Diagnostic Test: Formal ultrasoundPoint of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks |
| Routine antenatal care | Active comparator | Diagnostic Test: Routine antenatal care, Diagnostic Test: Formal ultrasoundRoutine 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Point of care ultrasound (POC-US) |
| Routine antenatal careRoutine 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 | Routine antenatal care |
| Formal ultrasoundFormal growth ultrasound performed between 36-38.6 weeks by RDMS. | Diagnostic test | Point of care ultrasound (POC-US), Routine antenatal care |
Primary outcome
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
20 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of participants with composite maternal morbidity
Time frame: labor until delivery (total time is about 1-48 hrs)
Total costs of care from the health system perspective
Time frame: from time of randomization until discharge (total time is about 15 weeks)
Results and safety
The study was stopped early (reason given: COVID related termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Bicocca, MD principal investigator
University of Texas Health Science Center of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound (POC-US), Routine antenatal care and Formal ultrasound in people with Fetal Growth Abnormality and Amniotic Fluid; Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID related termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with abnormal fetal growth or amniotic fluid (time frame: From 28 weeks Gestational age (GA) to 36 weeks GA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.