- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169390
Monoamine Oxidases in Smoking Pregnant Women and Newborns
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
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- pregnancy of 5 or 6 months
- 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:
- pathological pregnancies
- opioid dependence; alcoholism.
- chronic psychiatric, hematological, neurological disorders
- eclampsia
- chronic antidepressant or neuroleptic treatment
- current nicotine replacement therapies
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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pregnant smokers
|
pregnant non smokers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
monoamine oxidase markers
Time Frame: at birth
|
at birth
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Ivan Berlin, MD, PhD, Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
Publications and helpful links
General Publications
- 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. Erratum In: Biol Psychiatry. 2009 Nov 15;66(10):985.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RBM0344
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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