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

NCT ID: NCT03857659

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-05
• Study Completion Date: 2020-05-20

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

Study Design

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

Study Groups

Point of care ultrasound (POC-US)

Point of care ultrasound (POC-US) to measure abdominal circumference and amniotic fluid every 4 weeks from 28-36 weeks

Group Type: EXPERIMENTAL

Point-of-care ultrasound (POC-US)

Intervention Type: 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.

Formal ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Routine antenatal care

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)

Group Type: ACTIVE_COMPARATOR

Routine antenatal care

Intervention Type: 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)

Formal ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Point-of-care ultrasound (POC-US)

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.

Intervention Type: DIAGNOSTIC_TEST

Routine antenatal care

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)

Intervention Type: DIAGNOSTIC_TEST

Formal ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Bicocca, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center of Houston

Locations

University of Texas Health Science Center of Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-18-1074

Identifier Type: -

Identifier Source: org_study_id