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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD115604-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
Pregnant study participants will be recruited and monitored throughout pregnancy with ultrasound and blood draws, and delivery and neonatal data up to 28 days following birth. This data will be used to develop a model to predict placental insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort | Pregnant people age 15 and older, without known major fetal anatomic or genetic abnormalities, singleton gestation will be monitored via ultrasound and blood tests throughout pregnancy. Delivery data and neonatal outcomes will be collected. Data will be used to develop a predictive model of placental insufficiency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Collection Throughout Pregnancy and Delivery | Other | Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with placental insufficiency composite | The composite is made of the following: stillbirth and neonatal death, severe forms of hypertensive disease, placental abruption, birthweight below the 3rd percentile, umbilical cord arterial pH<7, and/or placental primary indication for delivery (FGR, oligohydramnios, abnormal fetal testing) | At time of delivery to 28 days following delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant people age 15 and older, parous and nulliparous, without known major fetal anatomic or genetic abnormalities. Participants must be pregnant with a singleton living gestation, less than 22 weeks' gestation at enrollment, and planning to deliver at Oregon Health & Science University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Women's Health Research Unit Department of Ob/Gyn | Contact | 503-494-3666 | whru@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen Gibbins | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D010927 | Placental Insufficiency |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D036801 | Parturition |
| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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Serum and plasma without DNA will be retained in the OHSU repository for potential future research.
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010922 | Placenta Diseases |