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Obstetric Complications in Women Who Smoke During Pregnancy

This study is not yet open for participant recruitment.
Verified December 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01758276
First received: December 26, 2012
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Smoking

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Obstetric Complications in Women Who Smoke During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Neonatal Intensive Care Unit admission rate in women who smoke in pregnancy [ Time Frame: pregnancy 40 weeks ] [ Designated as safety issue: No ]
    Using the MOND database We will assess NICU admission rate of babies to women who smoke


Secondary Outcome Measures:
  • Birthweight [ Time Frame: 40 weeks of pregnancy ] [ Designated as safety issue: No ]
    we will assess birth weight of babies to mothers who smoke Vs those who don't


Estimated Enrollment: 21000
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non smokers
Women who did not report smoking in pregnancy
Smokers in pregnancy
Women who report smoking in pregnancy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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..)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01758276     History of Changes
Other Study ID Numbers: 0092-12
Study First Received: December 26, 2012
Last Updated: December 31, 2012
Health Authority: Israel: "Hillel Yaffe Medical Center Hadera"

Keywords provided by Hillel Yaffe Medical Center:
smoking, pregnancy

Additional relevant MeSH terms:
Smoking
Obstetric Labor Complications
Habits
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013