Obstetric Complications in Women Who Smoke During Pregnancy | NCT01758276

Studies
Obstetric Complications in Women Who Smoke During Pregnancy

NCT01758276

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jan 1, 2013Estimated

Enrollment

21,000Estimated

Phase

Not provided

Conditions

Smoking

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Dec 26, 2012

First Submission Date that Met QC Criteria

Dec 31, 2012

First Posted Date

Jan 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2012

Last Update Posted Date

Jan 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non smokers		Women who did not report smoking in pregnancy
Smokers in pregnancy		Women who report smoking in pregnancy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Birthweight	we will assess birth weight of babies to mothers who smoke Vs those who don't	40 weeks of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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..)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Shrim, MD	Contact	972506246988		alon.shrim@gmail.com

Overall Officials

Name	Affiliation	Role
Alon Shrim, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Not provided