Early Pregnancy Evaluation by Three-Dimensional Ultrasound
Stopped early
Conditions studied: First Trimester Bleeding, Pregnancy
In brief
Early pregnancy is associated with numerous physiologic alterations - many of which are required to establish normal pregnancy outcome. Three-dimensional ultrasound may provide new opportunities to better characterize some of these early changes. This noninvasive method allows one to arbitrarily scan through a digital ultrasound volume data, visualize organs from different perspectives, and render anatomical features through computer processing. Retrospective measurement of distances and volumes are even possible in the physical absence of the patient. New information provided by three-dimensional ultrasound may lead to improved understanding about how to counsel parents regarding early pregnancy complications such as bleeding. For example, vaginal bleeding complicates approximately 15-20% of first trimester pregnancies. A common association is subchorionic hemorrhage which is associated with increased risk for miscarriage, preterm delivery, preterm premature rupture of membranes, stillbirth, and placental abruption. Several studies have attempted to characterize subchorionic hemorrhage by conventional two-dimensional ultrasound which is not particularly well-suited for accurate measurement of small irregular hematomas. Consequently, there has been considerable debate about the significance of this finding especially in asymptomatic women who undergo prenatal ultrasound examination for other reasons. This protocol will attempt to identify prognostic indicators of adverse pregnancy outcome. A maximum of 400 pregnant women up to 20 weeks' gestation with sonographically detected subchorionic hemorrhage will be serially studies to characterize sac volume, placental volume, hematoma volume, and placental blood vessel patterns by 3DUS techniques. These results will be correlated with pregnancy outcome, hormonal markers, and placental pathology. This information is expected to improve our understanding of the natural history of subchorionic bleeding and spontaneous miscarriages as well as prognostic factors influencing pregnancy outcome in both symptomatic and asymptomatic women.
Key facts
- Study ID
- NCT00342290
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 69
- Starts
- 1998-03-22
- Expected to finish
- 2012-06-29
- Last updated by the study team
- 2019-12-17
Who can join
Age: 15 and older. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- Poor visualization of the fetus due to technical factors (e.g. obesity).
- Risk factors that increase risk for not keeping serial ultrasound appointments.
- Desire not to have vaginal ultrasound scans.
Where it is running
- Hutzel Women's Hospital — Detroit, Michigan, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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