Point of Care Ultrasound Screening for Abnormal Fetal Growth During Routine Antenatal Visits

NCT ID: NCT03715036

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2020-03-30

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.

Detailed Description

The prior studies of routine ultrasound in low risk patients focused on the usual ultrasound evaluation which involves the use of advanced equipment and providers, including trained sonographers and physicians to perform and review the ultrasound, as well as a full examination with multiple fetal measurements and images. A number of recent analyses show that measurement of the 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, long time to acquire, or expensive ultrasound machines. They can be easily performed in the office by providers who are specifically trained in obtaining these 2 measurements. Therefore, we intended to evaluate if introduction of bedside ultrasound during routine antenatal visits (point of care ultrasound or POC-US) to evaluate fetal AC and amniotic fluid DVP would decrease the false positive rates of fundal height measurement in diagnosing intrauterine growth abnormalities, and would improve the diagnosis of amniotic fluid volume and fetal growth deviations.

Conditions

Prenatal Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fundal height

Patients will have routine fundal height measurement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Point-of-care US

Patients will receive POC US for DVP and AC.

Group Type: EXPERIMENTAL

Point-of-care US

Intervention Type: DIAGNOSTIC_TEST

The intervention includes reassuring the AC and DVP

Interventions

Point-of-care US

The intervention includes reassuring the AC and DVP

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Maternal age ≥ 18 years and ability to give informed consent

2. Singleton gestation

3. Ultrasound examination that confirms or revises the EDD before 22 0/7 weeks of gestational age (ACOG Committee opinion 2017 dating)

4. Gestational age ≥ 24 weeks gestation

Exclusion Criteria

1. Abnormal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT)

2. Fetal chromosomal or genetic abnormalities

3. Fetal malformations or soft markers identified on fetal anatomy survey

4. Current pregnancy is a result of in vitro fertilization

6. Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.

7. Cerclage in the current pregnancy

8. History of intrauterine fetal demise, small for gestational age, macrosomia or shoulder dystocia, or of traumatic delivery

9. Fetal isoimmunization or alloimmunization

10. 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 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, CMV, toxoplasmosis, parvovirus B19 Note that the aforementioned are just examples and any clinical indication for ultrasound examination after 24 weeks is an exclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saad Antonio

Role: PRINCIPAL_INVESTIGATOR

UTMB

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35032696 (View on PubMed)

Other Identifiers

IRB #: 18-0023

Identifier Type: -

Identifier Source: org_study_id