Clinical trial NCT01992744: BDNF Pregnancy Study
Official title: Peripheral Serum BDNF Levels and Poor Birth Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
brain-derived neurotrophic factor
birth outcomes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neuropeptide & Blood Levels
timeFrame: First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum)
Secondary outcomes:
measure: Clinician and Patient Ratings
timeFrame: First Trimester (8 weeks to 12 weeks gestational age), Third Trimester (28 weeks to 32 weeks gestational age) & Postpartum (30 days postpartum)
Other outcomes:
measure: Birth Outcomes
timeFrame: Postpartum (30 days postpartum)
Locations:
city: Philadelphia
country: United States
facility: 3701 Market Street
state: Pennsylvania
city: Philadelphia
country: United States
facility: Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Center for Women's Behavioral Wellness
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Medicine Washington Square (PMWS)
state: Pennsylvania
Study officials:
affiliation: Assistant Professor University of Pennsylvania
name: Deborah R Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.