Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care: A Randomized Controlled Trial (STAR Trial)

The University of Texas Health Science Center, Houston1 site in 1 country113 target enrollmentApril 5, 2019

ConditionsFetal Growth Abnormality Amniotic Fluid; Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fetal Growth Abnormality
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 113
Locations: 1
Primary Endpoint: Number of participants with abnormal fetal growth or amniotic fluid
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 5, 2019

End Date

May 20, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Sponsor

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:

Outcomes

Primary Outcomes

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

Secondary Outcomes

Specificity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
Positive predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
Negative predictive value of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
Sensitivity of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
Sensitivity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
Specificity of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
Positive predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
False positive rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
False negative rate of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(From 28 weeks Gestational age (GA) to time of delivery)
Negative predictive value of diagnostic methods for identification of birthweight < 10th percentile or > 90th percentile(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(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
Positive likelihood ratio of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(From 28 weeks Gestational age (GA) to 38.6 weeks GA)
False negative rate of diagnostic methods for identification of abnormal fetal growth or amniotic fluid(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(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(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(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)
Total costs of care from the health system perspective(from time of randomization until discharge (total time is about 15 weeks))
Number of participants with composite neonatal morbidity(at delivery)
Number of participants with composite maternal morbidity(labor until delivery (total time is about 1-48 hrs))