Monoamine Oxidases in Smoking Pregnant Women and Newborns

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00169390
First received: September 9, 2005
Last updated: August 3, 2009
Last verified: August 2009
  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:

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)
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

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: September 9, 2005
Last Updated: August 3, 2009
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 14, 2014