Early Pregnancy Evaluation by Three-Dimensional Ultrasound
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - Any |
| Updated: | 4/5/2019 |
| Start Date: | March 22, 1998 |
| End Date: | June 29, 2012 |
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....
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....
Miscarriage is the most common outcome of pregnancy. Vaginal bleeding complicates up to 25%
of all pregnancies, and this clinical sign is associated with an increased risk of
spontaneous abortion (also known as miscarriage) and other adverse pregnancy outcomes, such
as spontaneous preterm labor, preterm premature rupture of the membranes, pre-eclampsia and
intrauterine growth restriction. Despite the importance of vaginal bleeding in clinical
obstetrics, there is inadequate understanding about the mechanisms leading to vaginal
bleeding, and of tests to predict pregnancy outcome in the majority of cases.
A common finding in patients with first trimester vaginal bleeding is subchorionic
hemorrhage, which is associated with an increased risk of miscarriage, preterm delivery,
preterm premature rupture of membranes, stillbirth, and placental abruption. Previous
attempts to characterize subchorionic hemorrhage have used two-dimensional ultrasound, which
is not well-suited for accurate measurement of the volume irregular hematomas. It is not
surprising that there has been debate about the significance of subchorionic hemorrhage,
especially in asymptomatic women undergoing prenatal ultrasound examination for other reasons
in which an intrauterine hematoma is found. Three-dimensional ultrasonography has the
potential to improve the characterization of volume and location of intrauterine hematomas.
This information may be of value in predicting pregnancy outcome.
The Perinatology Research Branch proposes that first trimester bleeding is one of the great
obstetrical syndromes; conditions characterized by a collection of signs and symptoms (in
this case vaginal bleeding and cramping), with multiple etiologies. We propose that first
trimester bleeding may be the result of a hemostatic disorder of the prenatal endometrium
(deciduas), caused by pathologic factors including (1) genetic disorders such as chromosomal
abnormalities which often is the result in miscarriage in the first trimester of pregnancy;
(2) congenital or acquired hemostatic abnormalities due to thrombophilic mutations; (3)
abnormal endocrine processes which may lead to dysregulation of endometrial events required
for successful pregnancy; (4) abnormal immunological responses in the maternal/embryo/fetal
interface. These abnormalities, which could have clinical significance, cannot be
investigated with ultrasound. This protocol describes a comprehensive and systematic study of
women who present with bleeding during the first trimester of pregnancy, to improve
understanding of the relationship between the location and the size of hematomas (with
three-dimensional ultrasounds) and the other factors that may determine the subsequent
development of adverse pregnancy outcome.
The Branch will execute this protocol by establishing a first-trimester clinic to study
patients who present with this common complication of pregnancy. First trimester bleeding is
a common and important complication of pregnancy which has been a neglected area of
investigation by private and public agencies. We intend to address what has been an orphan
area of clinical research.
of all pregnancies, and this clinical sign is associated with an increased risk of
spontaneous abortion (also known as miscarriage) and other adverse pregnancy outcomes, such
as spontaneous preterm labor, preterm premature rupture of the membranes, pre-eclampsia and
intrauterine growth restriction. Despite the importance of vaginal bleeding in clinical
obstetrics, there is inadequate understanding about the mechanisms leading to vaginal
bleeding, and of tests to predict pregnancy outcome in the majority of cases.
A common finding in patients with first trimester vaginal bleeding is subchorionic
hemorrhage, which is associated with an increased risk of miscarriage, preterm delivery,
preterm premature rupture of membranes, stillbirth, and placental abruption. Previous
attempts to characterize subchorionic hemorrhage have used two-dimensional ultrasound, which
is not well-suited for accurate measurement of the volume irregular hematomas. It is not
surprising that there has been debate about the significance of subchorionic hemorrhage,
especially in asymptomatic women undergoing prenatal ultrasound examination for other reasons
in which an intrauterine hematoma is found. Three-dimensional ultrasonography has the
potential to improve the characterization of volume and location of intrauterine hematomas.
This information may be of value in predicting pregnancy outcome.
The Perinatology Research Branch proposes that first trimester bleeding is one of the great
obstetrical syndromes; conditions characterized by a collection of signs and symptoms (in
this case vaginal bleeding and cramping), with multiple etiologies. We propose that first
trimester bleeding may be the result of a hemostatic disorder of the prenatal endometrium
(deciduas), caused by pathologic factors including (1) genetic disorders such as chromosomal
abnormalities which often is the result in miscarriage in the first trimester of pregnancy;
(2) congenital or acquired hemostatic abnormalities due to thrombophilic mutations; (3)
abnormal endocrine processes which may lead to dysregulation of endometrial events required
for successful pregnancy; (4) abnormal immunological responses in the maternal/embryo/fetal
interface. These abnormalities, which could have clinical significance, cannot be
investigated with ultrasound. This protocol describes a comprehensive and systematic study of
women who present with bleeding during the first trimester of pregnancy, to improve
understanding of the relationship between the location and the size of hematomas (with
three-dimensional ultrasounds) and the other factors that may determine the subsequent
development of adverse pregnancy outcome.
The Branch will execute this protocol by establishing a first-trimester clinic to study
patients who present with this common complication of pregnancy. First trimester bleeding is
a common and important complication of pregnancy which has been a neglected area of
investigation by private and public agencies. We intend to address what has been an orphan
area of clinical research.
- 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.
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