Monoamine Oxidases in Smoking Pregnant Women and Newborns

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169390
• Other study ID #: RBM0344
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: March 17, 2015
• Start date: March 2004
• Est. completion date: November 2007

Study information

• Verified date: August 2009
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Newborn
• Pregnancy
• Smoking

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Institut National de la Santé Et de la Recherche Médicale, France, Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie (MILDT), Mutuelle Générale de l'Education Nationale (MGEN)

References & Publications (1)

Berlin I, Anthenelli RM. Monoamine oxidases and tobacco smoking. Int J Neuropsychopharmacol. 2001 Mar;4(1):33-42. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monoamine oxidase markers		at birth