Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
Study NCT ID:
NCT02948192
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2016-10-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Reproductive Microbiome & Perinatal Health Outcomes
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
The Reproductive Microbiome & Perinatal Health Outcome
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to obtain final specimen routinely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: