Clinical trial NCT03857659: Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care
Official title: Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Growth Abnormality
Amniotic Fluid; Disorder
Keywords: Pregnancy
Ultrasound
neonatal morbidity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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

Primary outcomes:
measure: Number of participants with abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 36 weeks GA
measure: Number of participants with abnormal fetal growth or amniotic fluid
timeFrame: From 36 weeks Gestational age (GA) to 38.6 weeks GA
Secondary outcomes:
measure: Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Sensitivity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Specificity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Specificity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Positive predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Positive predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Negative predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Negative predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: False positive rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: False positive rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: False negative rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: False negative rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Positive likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Positive likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Negative likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid
timeFrame: From 28 weeks Gestational age (GA) to 38.6 weeks GA
measure: Negative likelihood ratio of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile
timeFrame: From 28 weeks Gestational age (GA) to time of delivery
measure: Number of referrals for formal USE.
timeFrame: From 28 weeks Gestational age (GA) to 36 weeks GA
measure: Number of participants with composite neonatal morbidity
timeFrame: at delivery
measure: Number of participants with composite maternal morbidity
timeFrame: labor until delivery (total time is about 1-48 hrs)
measure: Total costs of care from the health system perspective
timeFrame: from time of randomization until discharge (total time is about 15 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center of Houston
state: Texas
Study officials:
affiliation: University of Texas Health Science Center of Houston
name: Matthew Bicocca, MD
role: PRINCIPAL_INVESTIGATOR
References: