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



Status:Not yet recruiting
Healthy:No
Age Range:18 - 50
Updated:3/2/2019
Start Date:March 15, 2019
End Date:August 31, 2020
Contact:Matthew Bicocca, MD
Email:Matthew.Bicocca@uth.tmc.edu
Phone:7135006421

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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).


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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-500-6421
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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mi
from
Houston, TX
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