Placental Insufficiency, Stillbirth
Conditions
Brief summary
This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.
Detailed description
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.
Interventions
OTHERData Collection Throughout Pregnancy and Delivery
Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant * Age 15 or older * No known major fetal anatomic or genetic abnormalities * Singleton gestation * Planning to deliver at Oregon Health & Science University * Prior to 22 weeks' gestation
Exclusion criteria
* Decisional impairment * Multiple gestation * Known fetal growth restriction or major congenital anomaly * Inability to consent * Inability to attend study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with placental insufficiency composite | At time of delivery to 28 days following delivery | 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) |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Department of Ob/Gyn
Outcome results
None listed