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

NCT03857659 | Terminated FDA Device

• 1 other identifier: HSC-MS-18-1074
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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).

Conditions

Fetal Growth Abnormality; Amniotic Fluid; Disorder

Keywords

Pregnancy; Ultrasound; neonatal morbidity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (20)

• 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 abnormal fetal growth or amniotic fluid

  From 28 weeks Gestational age (GA) to 38.6 weeks GA

• 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 abnormal fetal growth or amniotic fluid

  From 28 weeks Gestational age (GA) to 38.6 weeks GA

Study Arms (2)

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

Diagnostic Test: Point-of-care ultrasound (POC-US); Diagnostic Test: Formal ultrasound

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)

Diagnostic Test: Routine antenatal care; Diagnostic Test: Formal ultrasound

Interventions

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.

Point of care ultrasound (POC-US)

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)

Routine antenatal care

Formal ultrasound DIAGNOSTIC_TEST

Formal growth ultrasound performed between 36-38.6 weeks by RDMS.

Point of care ultrasound (POC-US); Routine antenatal care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Matthew Bicocca, MD

  University of Texas Health Science Center of Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: April 5, 2019
• Primary Completion: March 20, 2020
• Study Completion: May 20, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)