NCT03715036

Brief Summary

Abdominal circumference (AC) in the fetus is the single most useful indicator of fetal growth abnormalities. Measurement of AC as well as DVP do not require extensive training. Our objective is to evaluate if introduction of bedside ultrasound during routine antenatal visits to evaluate fetal AC and amniotic fluid DVP would decrease the false positive rates of fundal height measurement in diagnosing intrauterine growth abnormalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

September 5, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

October 16, 2018

Last Update Submit

September 2, 2021

Conditions

Prenatal Disorder

Outcome Measures

Primary Outcomes (1)

  • Growth abnormalities rate

    To compare the false positive rates between clinical evaluation of uterine size by SFH versus POC-US evaluation of AC and DVP.

    Up to 2 years

Secondary Outcomes (3)

  • MFM ultrasounds

    Up to 2 years

  • Clinical evaluation

    Up to 2 years

  • Maternal and neonatal outcomes

    Up to 2 years

Study Arms (2)

Fundal height

NO INTERVENTION

Patients will have routine fundal height measurement

Point-of-care US

EXPERIMENTAL

Patients will receive POC US for DVP and AC.

Diagnostic Test: Point-of-care US

Interventions

Point-of-care USDIAGNOSTIC_TEST

The intervention includes reassuring the AC and DVP

Point-of-care US

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Maternal age ≥ 18 years and ability to give informed consent
  • Singleton gestation
  • Ultrasound examination that confirms or revises the EDD before 22 0/7 weeks of gestational age (ACOG Committee opinion 2017 dating)
  • 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, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.
  • Cerclage in the current pregnancy
  • History of intrauterine fetal demise, small for gestational age, macrosomia or shoulder dystocia, or of traumatic delivery
  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • Omere C, Goncharov DA, Pedroza C, La Rosa M, Munn M, Chiossi G, Longo M, Saad AF. Randomized trial of fundal height vs point-of-care ultrasound during routine antenatal visits. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100563. doi: 10.1016/j.ajogmf.2022.100563. Epub 2022 Jan 13. No abstract available.

    PMID: 35032696DERIVED

Study Officials

  • Saad Antonio

    UTMB

    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

October 16, 2018

First Posted

October 22, 2018

Study Start

April 29, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

September 5, 2021

Record last verified: 2021-06

Locations

US(1)