Monoamine Oxidases in Smoking Pregnant Women and Newborns

NCT ID: NCT00169390

Last Updated: 2015-03-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Pregnancy Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT)

UNKNOWN

Sponsor Role collaborator

Mutuelle Générale de l'Education Nationale (MGEN)

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

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.

Reference Type BACKGROUND
PMID: 11343627 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19615672 (View on PubMed)

Other Identifiers

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RBM0344

Identifier Type: -

Identifier Source: org_study_id

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