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Monoamine Oxidases in Smoking Pregnant Women and Newborns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169390
First Posted: September 15, 2005
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT)
Mutuelle Générale de l'Education Nationale (MGEN)
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  Purpose

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.


Condition
Smoking Pregnancy Newborn

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

Primary Outcome Measures:
  • monoamine oxidase markers [ Time Frame: at birth ]

Biospecimen Retention:   Samples Without DNA
plasma DHPG, HVA, 5HIAA, 5HT, cotinine

Enrollment: 59
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
pregnant smokers
pregnant non smokers

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant smoking or not smoking women
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169390


Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT)
Mutuelle Générale de l'Education Nationale (MGEN)
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Chair: Ivan Berlin, MD, PhD Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ivan Berlin, Groupe Hospitalier Pitie-Salpetriere, INSERM U677
ClinicalTrials.gov Identifier: NCT00169390     History of Changes
Other Study ID Numbers: RBM0344
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: March 19, 2015
Last Verified: August 2009

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
smoking
pregnancy
newborns
monoamine oxidases