Monoamine Oxidases in Smoking Pregnant Women and Newborns
NCT ID: NCT00169390
Last Updated: 2015-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2004-03-31
2007-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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pregnant smokers
No interventions assigned to this group
pregnant non smokers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* nonsmokers: lifetime smoking of less than 100 cigarettes; smokers: unable to stop smoking during the first 3 months of pregnancy; smoking at least 10 cigarettes/day.
Exclusion Criteria
* opioid dependence; alcoholism.
* chronic psychiatric, hematological, neurological disorders
* eclampsia
* chronic antidepressant or neuroleptic treatment
* current nicotine replacement therapies
18 Years
FEMALE
No
Sponsors
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Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT)
UNKNOWN
Mutuelle Générale de l'Education Nationale (MGEN)
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Groupe Hospitalier Pitie-Salpetriere
OTHER
Responsible Party
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Groupe Hospitalier Pitie-Salpetriere, INSERM U677
Principal Investigators
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Ivan Berlin, MD, PhD
Role: STUDY_CHAIR
Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
References
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Berlin I, Anthenelli RM. Monoamine oxidases and tobacco smoking. Int J Neuropsychopharmacol. 2001 Mar;4(1):33-42. doi: 10.1017/S1461145701002188.
Berlin I, Heilbronner C, Georgieu S, Meier C, Launay JM, Spreux-Varoquaux O. Reduced monoamine oxidase A activity in pregnant smokers and in their newborns. Biol Psychiatry. 2009 Oct 15;66(8):728-33. doi: 10.1016/j.biopsych.2009.05.029. Epub 2009 Jul 17.
Other Identifiers
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RBM0344
Identifier Type: -
Identifier Source: org_study_id
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