Obstetric Complications in Women Who Smoke During Pregnancy

Smoking Clinical Trial

Official title:

Obstetric Complications in Women Who Smoke During Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01758276
• Other study ID #: 0092-12
• Status: Not yet recruiting
• Phase: N/A
• First received: December 26, 2012
• Last updated: December 31, 2012
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2012
• Source: Hillel Yaffe Medical Center
• Contact: Alon Shrim, MD
• Phone: 972506246988
• Email: alon.shrim[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: "Hillel Yaffe Medical Center Hadera"
• Study type: Observational

Clinical 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. Obstetric complications will be recorded in both groups.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21000
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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..)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pregnancy 40 weeks	No
Secondary	Birthweight	we will assess birth weight of babies to mothers who smoke Vs those who don't	40 weeks of pregnancy	No