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Completed

NCT Number: NCT00169390

Monoamine Oxidases in Smoking Pregnant Women and Newborns

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.

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Key information

Conditions

Smoking Behavior Newborn Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. monoamine oxidase markers

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie
  • Mutuelle Générale de l'Education Nationale (MGEN)

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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