First Trimester BleedingNCT00342290
Early Pregnancy Evaluation by Three-Dimensional Ultrasound
An observational study of First Trimester Bleeding and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- First Trimester Bleeding, Pregnancy
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 1998to 29 Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hutzel Women's Hospital
Detroit, Michigan, 48201
William Beaumont Hospital
Royal Oak, Michigan, 48073-6769
About this study
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.
Read the detailed description
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.
- Conditions
- First Trimester Bleeding, Pregnancy
- Keywords
- Pathophysiological Volume Measurement, Power Doppler Ultrasound, Prediction of Adverse Pregnancy Outcome, Subchorionic Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start22 Mar 1998
- Study completion29 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for First Trimester BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Roberto Romero, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342290
- Sponsor's protocol ID
- 999998018
- Other IDs
- OH98-CH-N018
- Status last verified
- 29 Jun 2012
- First submitted
- 19 Jun 2006
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
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. doi: 10.1016/s0002-9378(87)80280-6.
PubMed 3688068Stabile I, Campbell S, Grudzinskas JG. Threatened miscarriage and intrauterine hematomas. Sonographic and biochemical studies. J Ultrasound Med. 1989 Jun;8(6):289-92. doi: 10.7863/jum.1989.8.6.289.
PubMed 2472492Bloch 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.
PubMed 2677693
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pregnancy Evaluation by Three-Dimensional Ultrasound
- ClinicalTrials.gov ID
- NCT00342290
- Acronym / sponsor ID
- 999998018
- Conditions
- First Trimester Bleeding, Pregnancy
- Keywords
- Pathophysiological Volume Measurement, Power Doppler Ultrasound, Prediction of Adverse Pregnancy Outcome, Subchorionic Hemorrhage
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 22 Mar 1998
- Study completion
- 29 Jun 2012
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 3688068Strobino 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. doi: 10.1016/s0002-9378(87)80280-6.
- Background: PubMed 2472492Stabile I, Campbell S, Grudzinskas JG. Threatened miscarriage and intrauterine hematomas. Sonographic and biochemical studies. J Ultrasound Med. 1989 Jun;8(6):289-92. doi: 10.7863/jum.1989.8.6.289.
- Background: PubMed 2677693Bloch 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Romero, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Trimester Bleeding and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00342290, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.