SmokingNCT01758276
Obstetric Complications in Women Who Smoke During Pregnancy
An observational study of Smoking, run by Hillel Yaffe Medical Center.
Trial summary
This will be a retrospective study. Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Smoking
- How many people
- 21,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2014
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women who delivered in McGill University health center between 2001-2008
Who may be able to join
- All women who delivered in McGill University health center between 2001-2008
Who cannot join
- delivery prior to 24 weeks (data on <24 weeks not included in the database..)
Trial locations and contacts
No sites are listed yet.
About this study
This will be a retrospective study. Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.
Read the detailed description
This will be a retrospective study using the McGill University Obstetrics and Neonatal database (MOND). This is a comprehensive database the contains details on all women delivering in McGill University Health Center in Montreal Canada.
Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.
Statistic tests would be applied in order to assess relation between smoking and Obstetrical complications.
- Conditions
- Smoking
- Keywords
- smoking, pregnancy
- 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 |
|---|---|---|
| Non smokers | Women who did not report smoking in pregnancy | |
| Smokers in pregnancy | Women who report smoking in pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Intensive Care Unit admission rate in women who smoke in pregnancy
Using the MOND database We will assess NICU admission rate of babies to women who smoke
Measured: pregnancy 40 weeks
Secondary outcomes (1)
Birthweight
we will assess birth weight of babies to mothers who smoke Vs those who don't
Measured: 40 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alon Shrim, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758276
- Sponsor's protocol ID
- 0092-12
- Status last verified
- Dec 2012
- First submitted
- 26 Dec 2012
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Complications in Women Who Smoke During Pregnancy
- ClinicalTrials.gov ID
- NCT01758276
- Acronym / sponsor ID
- 0092-12
- Conditions
- Smoking
- Keywords
- smoking, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,000 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Jan 2013 (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.
This will be a retrospective study. Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.
Detailed description
This will be a retrospective study using the McGill University Obstetrics and Neonatal database (MOND). This is a comprehensive database the contains details on all women delivering in McGill University Health Center in Montreal Canada.
Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.
Statistic tests would be applied in order to assess relation between smoking and Obstetrical complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non smokers | – | –Women who did not report smoking in pregnancy |
| Smokers in pregnancy | – | –Women who report smoking in pregnancy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women who delivered in McGill University health center between 2001-2008
Key inclusion criteria (1 listed)
- All women who delivered in McGill University health center between 2001-2008
Key exclusion criteria (1 listed)
- delivery prior to 24 weeks (data on <24 weeks not included in the database..)
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
Neonatal Intensive Care Unit admission rate in women who smoke in pregnancy
Time frame: pregnancy 40 weeks
Using the MOND database We will assess NICU admission rate of babies to women who smoke
1 secondary outcome
Birthweight
Time frame: 40 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
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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.
Alon Shrim, MD principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by Hillel Yaffe Medical Center.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jan 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Shrim, MD (972506246988, alon.shrim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Intensive Care Unit admission rate in women who smoke in pregnancy (time frame: pregnancy 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2013.