Can a specialised antenatal clinic help pregnant women quit smoking and reduce the risk of complications for mother and baby?

Not Applicable

Completed

• Conditions: Smoking in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN11214785
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31481110 protocol 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36216314/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-08
• Study Completion: 2020-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 434

Inclusion Criteria

1. = 18yrs old
2. Singleton pregnancy
3. Smoking = 1 cigarette daily
4. English language spoken

Exclusion Criteria

1. Significant maternal medical disorder, eg. cardiac, haematological or endocrine disease (including GDM on metformin or insulin) requiring specialised maternal antenatal care.
2. Significant maternal psychiatric disorder, eg. delusional or psychotic disorders, severe depression requiring hospitalisation, use of =2 psychotropic drugs for treatment.
3. Serious co-morbid addiction issues eg opiate abuse, methadone maintenance program
4. Positive serology requiring specialised antenatal care
5. Significant fetal anomaly defined as aneuploidy, life limiting or lethal fetal anomaly
6. Intellectual disability or lack of capacity
7. Poor English / No English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported continuous abstinence from smoking between the quit date and end of pregnancy (quit date is targeted as being at or before 16 weeks gestation and no further than 28 weeks gestation). This is validated using the exhaled carbon monoxide (CO) or urinary cotinine measured at one week, four weeks, three months and six months post quit date.