Clinical trial NCT00169390: Monoamine Oxidases in Smoking Pregnant Women and Newborns
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Pregnancy
Newborn
Keywords: smoking
pregnancy
newborns
monoamine oxidases
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT)
name: Mutuelle Générale de l'Education Nationale (MGEN)
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2005-09-15
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant smoking or not smoking women

Brief summary: 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: 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 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

Primary outcomes:
measure: monoamine oxidase markers
timeFrame: at birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
name: Ivan Berlin, MD, PhD
role: STUDY_CHAIR
References:
citation: Berlin I, Anthenelli RM. Monoamine oxidases and tobacco smoking. Int J Neuropsychopharmacol. 2001 Mar;4(1):33-42. doi: 10.1017/S1461145701002188.
citation: 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.