BDNF Pregnancy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Peripheral Serum BDNF Levels and Poor Birth Outcomes

Conditions
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Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be at least 18 years old and being treated at an outpatient OB/GYN clinic; At least 8 weeks pregnant; Capable of giving informed consent. Exclusion Criteria: Participants younger than 18 years of age; History of preterm birth; Psychiatric medications during current pregnancy; Participants with a history of hematologic disorders; Participants who refuse informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Pregnant Women<br>Participants 8 to 12 weeks gestational age as determined by their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropeptide & Blood Levels | BDNF Complete blood count (CBC) | First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician and Patient Ratings | Edinburgh Postnatal Depression Score (EPDS) Perceived Stress Scale Score (PSS) Adverse Childhood Events Questionnaire Score (ACEs) Beck Depression Inventory (BDI) Brief Anxiety Inventory (BAI) Brief Symptom Inventory (BSI) | First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, brain-derived neurotrophic factor, birth outcomes