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Obstetric Complications in Women Who Smoke During Pregnancy

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ClinicalTrials.gov Identifier: NCT01758276
Recruitment Status : Unknown
Verified December 2012 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief 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. Obstetric complications will be recorded in both groups.

Condition or disease
Smoking

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 Type : Observational
Estimated Enrollment : 21000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Obstetric Complications in Women Who Smoke During Pregnancy
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Group/Cohort
Non smokers
Women who did not report smoking in pregnancy
Smokers in pregnancy
Women who report smoking in pregnancy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Birthweight [ Time Frame: 40 weeks of pregnancy ]
    we will assess birth weight of babies to mothers who smoke Vs those who don't



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All women who delivered in McGill University health center between 2001-2008
Criteria

Inclusion Criteria:all

  • All women who delivered in McGill University health center between 2001-2008

Exclusion Criteria:

  • delivery prior to 24 weeks (data on <24 weeks not included in the database..)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758276


Contacts
Contact: Alon Shrim, MD 972506246988 alon.shrim@gmail.com

Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Alon Shrim, MD Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01758276     History of Changes
Other Study ID Numbers: 0092-12
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: January 1, 2013
Last Verified: December 2012

Keywords provided by Hillel Yaffe Medical Center:
smoking, pregnancy