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

Stopped early · Not applicable

Conditions studied: Fetal Growth Abnormality, Amniotic Fluid; Disorder

In brief

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).

Key facts

Study ID

NCT03857659

Run by

The University of Texas Health Science Center, Houston

People needed

113

Starts

2019-04-05

Expected to finish

2020-05-20

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Health Science Center of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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