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The purpose of this study is to evaluate the correlation between varying levels of neuropeptides and birth outcomes. Neuropeptides are substances (proteins) produced in the body in very small amounts but without which the nervous system cannot function properly, and which might have a role in the health of a newborn. As part of this study, we are collecting blood samples from pregnant women.
Neuropeptides and hormones can be measured in blood. This study will involve three blood draws from the participants arm. Demographic information will also be requested, and participants will be asked to complete questionnaires about their mood and personal experiences at each visit.
Our hypothesis is that participants with lower levels of brain-derived neurotrophic factor (BDNF) will be at increased risk for poor birth outcomes.
This prospective, non-randomized trial will evaluate peripheral serum blood levels of BDNF in participants recruited from previously identified University of Pennsylvania obstetrics and gynecological (OB/GYN) clinics. A total of 100 pregnant subjects will be recruited consecutively and evaluated in the first and third trimester of their pregnancy as well as within a month after delivery.
The entire project will take one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Pregnant Women | Participants 8 to 12 weeks gestational age as determined by their physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Neuropeptide & Blood Levels |
| First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician and Patient Ratings |
| First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) |
| Measure | Description | Time Frame |
|---|---|---|
| Birth Outcomes |
|
Inclusion Criteria:
Exclusion Criteria:
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Women from the greater Philadelphia and surrounding areas who are ages 18 to 39 and between 8 to 12 weeks pregnant will be considered for enrollment into this study. All subjects must be physically healthy without a serious, major medical illness as well as be carrying a healthy fetus. Subject will be enrolled through OB/GYN waiting room recruiting, fliers, advertisements and social media outlets.
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| Name | Affiliation | Role |
|---|---|---|
| Deborah R Kim, M.D. | Assistant Professor University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3701 Market Street | Philadelphia | Pennsylvania | 19104 | United States | ||
| Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kim DR, Gonzalez JM, Sammel MD, Parry S, Epperson CN. Brain Derived Neurotrophic Factor is Altered in Human Pregnancy. Clinical Neuropsychiatry 2012 Dec; 9(6):207-11. |
| Label | URL |
|---|---|
| Program Website | View source |
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- Brain-Derived Neurotrophic Factor
| Postpartum (30 days postpartum) |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania | 19104 | United States |
| Penn Medicine Washington Square (PMWS) | Philadelphia | Pennsylvania | 19107 | United States |