Stopping smoking to optimise pregnancy

Completed

• Conditions: Smoking cessation in pregnant women; Mental and Behavioural Disorders

• Registration Number: ISRCTN49741320
• Lead Sponsor: Coombe Women and Infants University Hospital (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-26
• Study Completion: 2016-09-30
• Last Update Posted: 22 October 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

Participant inclusion criteria as of 18/09/2018:
1. Age >18 years
2. <17 weeks gestation
3. Fluent in English
4. Ongoing singleton pregnancy
5. Self-reported smoker
6. Able to give written informed consent

Previous participant inclusion criteria:
1. Age >18 years
2. <24 weeks gestation
3. Fluent in English
4. Ongoing singleton pregnancy
5. Self-reported smoker
6. Able to give written informed consent

Exclusion Criteria

Participant exclusion criteria as of 18/09/2018:
1. Age <18 years
2. >17 weeks gestation
3. Non-English speaking
4. Multiple pregnancy
5. Non-smoker
6. Unable to give written informed consent

Previous participant exclusion criteria:
1. Age <18 years
2. >24 weeks gestation
3. Non-English speaking
4. Multiple pregnancy
5. Non-smoker
6. Unable to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measure as of 18/09/2018:<br>Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <17 weeks gestation and two months post recruitment.<br><br>Previous primary outcome measure:<br>Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal.