Ignite Creation Date:
2024-05-06 @ 2:13 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01992744
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2013-10-30
Brief Title:
BDNF Pregnancy Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Peripheral Serum BDNF Levels and Poor Birth Outcomes
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BDNF
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
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 OBGYN 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
The entire project will take one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None