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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | From 36 weeks Gestational age (GA) to 38.6 weeks GA |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 28 weeks Gestational age (GA) to 38.6 weeks GA |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Bicocca, MD | University of Texas Health Science Center of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center of Houston | Houston | Texas | 77030 | United States |
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|
| Routine antenatal care | Diagnostic 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 ultrasound | Diagnostic Test | Formal growth ultrasound performed between 36-38.6 weeks by RDMS. |
|
| 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 |
| 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | From 28 weeks Gestational age (GA) to time of delivery |
| Number of referrals for formal USE. | 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:
| at delivery |
| 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 | labor until delivery (total time is about 1-48 hrs) |
| 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. | from time of randomization until discharge (total time is about 15 weeks) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 1, 2022 | Aug 26, 2022 | 5 |