Fetal Anatomy by Three-Dimensional Ultrasound

NCT00340002 | Completed

• 2 other identifiers: 999997065OH97-CH-N065
• Study Type: observational
• Target: 3,650
• Locations: 1 country
• Sites: 2

Brief Summary

A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth. This capability allows clinicians to make prudent decisions regarding antepartum care, delivery site, and postnatal therapy. Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus. This technique allows one to scan through a digital ultrasound volume dataset, visualize organs from different perspectives, measure volumes, and render anatomical features through computer processing. However, the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy. We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound. A cross-sectional observational study of up to 1,400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages. The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography. All cases will be placed into a digital image database. For each anomaly category, volume reconstructions will be compared to normal anatomy at specific gestational ages. Key diagnostic findings will be documented and correlated with postnatal outcome. We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy.

Conditions

Preterm Birth; Pregnancy; Fetal Growth Abnormalities

Keywords

Fetal Anatomy; Pregnancy; Prenatal Diagnosis; Natural History

Outcome Measures

Primary Outcomes (1)

• Fetal Anatomy

  Data analysis is ongoing

  Ongoing

Study Arms (1)

Pregnant women

Pregnant women aged 18 years and older

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending Detroit Medical Center prenatal clinics in Detroit.

You may qualify if:

• All pregnant subjects will be recruited under informed consent at either Hutzel or William Beaumont Hospitals.
• The study population for both arms of this protocol will involve pregnant women greater than or equal to 15 years.
• CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:
• DUS STUDIES:
• No fetal anomalies suspected by 2DUS.
• Excellent visualization of normal fetal anatomy by 2DUS.
• Accurate dating criteria by 1st trimester scan and/or menstrual history.
• FETAL MRI STUDIES:
• Gestational age between 18-42 menstrual weeks.
• No known fetal abnormalities.
• CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:
• DUS STUDIES:
• Congenital anomaly suspected by 2DUS.
• Accurate dating criteria by 1st trimester scan and/or menstrual history.
• FETAL MRI STUDIES:

You may not qualify if:

• CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:
• DUS STUDIES:
• Poor visualization of the fetus due to technical factors (e.g. obesity, surgical scar).
• History of noncompliance with prenatal visits with the current or prior pregnancy.
• FETAL MRI STUDIES:
• Inability of the patient to fit in bore of MRI system.
• Metallic implants that would increase risk to patient.
• Previous occupational exposure to metal shop.
• History of claustrophobia.
• CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:
• DUS STUDIES:
• Poor fetal visualization from technical factors (e.g. obesity or decreased amniotic fluid).
• FETAL MRI STUDIES:
• Inability of the patient to fit in bore of MRI system.
• Metallic implants that would increase risk to patient.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (2)

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, United States

Location

Related Publications (3)

• Kuo HC, Chang FM, Wu CH, Yao BL, Liu CH. The primary application of three-dimensional ultrasonography in obstetrics. Am J Obstet Gynecol. 1992 Mar;166(3):880-6. doi: 10.1016/0002-9378(92)91355-e.

  PMID: 1550157 BACKGROUND

• Lee A, Deutinger J, Bernaschek G. "Voluvision": three-dimensional ultrasonography of fetal malformations. Am J Obstet Gynecol. 1994 May;170(5 Pt 1):1312-4. doi: 10.1016/s0002-9378(94)70148-2.

  PMID: 8178859 BACKGROUND

• Steiner H, Staudach A, Spitzer D, Schaffer H. Three-dimensional ultrasound in obstetrics and gynaecology: technique, possibilities and limitations. Hum Reprod. 1994 Sep;9(9):1773-8. doi: 10.1093/oxfordjournals.humrep.a138793.

  PMID: 7836537 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roberto Romero, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: November 26, 1997
• Primary Completion: November 18, 2016
• Study Completion: November 18, 2016
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (2)