Pregnancy
Conditions
Keywords
pregnancy, brain-derived neurotrophic factor, birth outcomes
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | * BDNF * Complete blood count (CBC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | * 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Birth Outcomes | Postpartum (30 days postpartum) | * Birth weight (low birth weight \< 2.5 kg; very low birth weight \< 1.5 kg) * APGAR score (at one minute, at five minutes) * Preterm birth (before 37 weeks gestation; very early preterm birth, before 35 weeks gestation); gestational age at delivery * Infant mortality/ Neonatal Intensive Care Unit (NICU) Admission * Major congenital malformations (especially neurologic) * Head circumference (cm) |
Countries
United States
Outcome results
None listed