Pregnancy Clinical Trial
Official title:
Early Pregnancy Evaluation by Three-Dimensional Ultrasound
Verified date | June 29, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 69 |
Est. completion date | June 29, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility |
- INCLUSION CRITERIA: All pregnant subjects will be recruited under informed consent at Hutzel Hospital. The study population for both arms of this protocol will involve pregnant women between the ages of 15 years-old and older at Hutzel Hospital. The ethnic backgrounds are estimated to involve approximately 60 percent Caucasian and 40 percent African American between both sides. - Accurate pregnancy dating criteria. - Estimated gestational age less than or equal to 20 weeks' gestation. - Visible fetus with normal heart rate and rhythm. EXCLUSION CRITERIA: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hutzel Women's Hospital | Detroit | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Bloch C, Altchek A, Levy-Ravetch M. Sonography in early pregnancy: the significance of subchorionic hemorrhage. Mt Sinai J Med. 1989 Sep;56(4):290-2. Review. — View Citation
Stabile I, Campbell S, Grudzinskas JG. Threatened miscarriage and intrauterine hematomas. Sonographic and biochemical studies. J Ultrasound Med. 1989 Jun;8(6):289-92. — View Citation
Strobino BA, Pantel-Silverman J. First-trimester vaginal bleeding and the loss of chromosomally normal and abnormal conceptions. Am J Obstet Gynecol. 1987 Nov;157(5):1150-4. — View Citation
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