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| ID | Type | Description | Link |
|---|---|---|---|
| OH98-CH-N016 |
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Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.
Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with maternal and fetal biological markers, placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Pregnant women aged 15 and older between 20 and 35 weeks with singleton gestation |
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| Measure | Description | Time Frame |
|---|---|---|
| Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery. | Data analysis is ongoing | Ongoing |
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INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:
3 Intact membranes;
4. Signed informed consent for voluntary participation and serial endovaginal scans.
EXCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:
INCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:
EXCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:
INCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:
EXCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:
INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:
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Pregnant women attending Hutzel Women's clinic at Detroit Medical Center
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Romero, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hutzel Women's Hospital | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3285274 | Background | Ayers JW, DeGrood RM, Compton AA, Barclay M, Ansbacher R. Sonographic evaluation of cervical length in pregnancy: diagnosis and management of preterm cervical effacement in patients at risk for premature delivery. Obstet Gynecol. 1988 Jun;71(6 Pt 1):939-44. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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