NCT01758276

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 26, 2012

Last Update Submit

December 31, 2012

Conditions

Smoking

Keywords

smoking, pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Birthweight

    40 weeks of pregnancy

Study Arms (2)

Non smokers

Women who did not report smoking in pregnancy

Smokers in pregnancy

Women who report smoking in pregnancy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alon Shrim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Shrim, MD

CONTACT

972506246988alon.shrim@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2012

First Posted

January 1, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 1, 2013

Record last verified: 2012-12