SmokingNCT00169390
Monoamine Oxidases in Smoking Pregnant Women and Newborns
An observational study of Smoking and Pregnancy, run by Groupe Hospitalier Pitie-Salpetriere.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant smoking or not smoking women
Who may be able to join
- 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.
Who cannot join
- pathological pregnancies
- opioid dependence; alcoholism.
- chronic psychiatric, hematological, neurological disorders
- eclampsia
- chronic antidepressant or neuroleptic treatment
- current nicotine replacement therapies
About this study
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
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.
Read the 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.
- Keywords
- smoking, pregnancy, newborns, monoamine oxidases
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant smokers | Not described | |
| pregnant non smokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
monoamine oxidase markers
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie, Mutuelle Générale de l'Education Nationale (MGEN), Institut National de la Santé Et de la Recherche Médicale, France
- Investigators
- Ivan Berlin, MD, PhD, Study chair, Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169390
- Sponsor's protocol ID
- RBM0344
- Status last verified
- Aug 2009
- First submitted
- 9 Sep 2005
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Berlin I, Anthenelli RM. Monoamine oxidases and tobacco smoking. Int J Neuropsychopharmacol. 2001 Mar;4(1):33-42. doi: 10.1017/S1461145701002188.
PubMed 11343627Berlin 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.
PubMed 19615672
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00169390
- Acronym / sponsor ID
- RBM0344
- Keywords
- smoking, pregnancy, newborns, monoamine oxidases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie, Mutuelle Générale de l'Education Nationale (MGEN), Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant smokers | – | – |
| pregnant non smokers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant smoking or not smoking women
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- pathological pregnancies
- opioid dependence; alcoholism.
- chronic psychiatric, hematological, neurological disorders
- eclampsia
- chronic antidepressant or neuroleptic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
monoamine oxidase markers
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Background: PubMed 11343627Berlin I, Anthenelli RM. Monoamine oxidases and tobacco smoking. Int J Neuropsychopharmacol. 2001 Mar;4(1):33-42. doi: 10.1017/S1461145701002188.
- Derived from this study: PubMed 19615672Berlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Berlin, MD, PhD study chair
Groupe Hospitalier Universitaire Pitié-Salpêtrière, Service de Pharmacologie and INSERM U677
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Pregnancy, run by Groupe Hospitalier Pitie-Salpetriere.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monoamine oxidase markers (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.