BDNF Pregnancy Study
BDNF
Peripheral Serum BDNF Levels and Poor Birth Outcomes
1 other identifier
observational
32
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 1, 2015
October 1, 2013
2.9 years
October 30, 2013
May 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Other Outcomes (1)
Birth Outcomes
Postpartum (30 days postpartum)
Study Arms (1)
Healthy Pregnant Women
Participants 8 to 12 weeks gestational age as determined by their physician.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
3701 Market Street
Philadelphia, Pennsylvania, 19104, United States
Helen O. Dickens Center for Women's Health, Hospital of the University of Pennsylvania
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
Related Publications (1)
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.
BACKGROUND
Related Links
Biospecimen
\- Brain-Derived Neurotrophic Factor
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah R Kim, M.D.
Assistant Professor University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 25, 2013
Study Start
May 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 1, 2015
Record last verified: 2013-10