Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169390
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2005-09-09
Brief Title:
Monoamine Oxidases in Smoking Pregnant Women and Newborns
Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Organization:
Groupe Hospitalier Pitie-Salpetriere
Study Overview
Official Title:
Comparison of Monoamines Oxidases A and B Activities and the Metabolism of Nicotine in Smoking and Nonsmoking Pregnant Women and in Their Newborns Evaluation of Their Effects on the Newborns Behavior
Status:
COMPLETED
Status Verified Date:
2009-08
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:
None
Brief Summary:
Smoking substantially inhibits the activities of both monamine oxidase MAO A and B enzymes
Aims of this study to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth
Aims of this study to compare MAO activities and nicotine and cotinine in peripheral blood of smoking and nonsmoking pregnant women in their placenta and in cord blood and relate them with the behavior of their newborns being observed during 48 hours after birth
Detailed Description:
40 pregnant smoking and 40 pregnant nonsmoking women will be included at the end of the 2nd trimester
Assessments smoking characteristics plasma cotinine DHPG DOPAC 5HIAA concentrations reflecting MAOA activity and platelet MAOB activity will be measured just after inclusion end of 2nd trimester just before delivery in venous maternal blood and just after delivery in cord blood
The newborns behavior wellbeing will be assessed every 8 hour after birth for 2 days
Comparisons will be made between smoking and nonsmoking women and their newborns
Assessments smoking characteristics plasma cotinine DHPG DOPAC 5HIAA concentrations reflecting MAOA activity and platelet MAOB activity will be measured just after inclusion end of 2nd trimester just before delivery in venous maternal blood and just after delivery in cord blood
The newborns behavior wellbeing will be assessed every 8 hour after birth for 2 days
Comparisons will be made between smoking and nonsmoking women and their newborns
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