Smoking in pregnancy Pregnancy and Childbirth Smoking in pregnancy
Conditions
Interventions
Current intervention as of 06/12/2018:
Women who smoke in pregnancy are randomised at first visit to either the STOP clinic or 'routine care'.
In the STOP clinic, they
Sponsors
Royal College of Surgeons in Ireland
Coombe Women and Infants University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. = 18yrs old 2. Singleton pregnancy 3. Smoking = 1 cigarette daily 4. English language spoken
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduced cigarette intake at 3 months post quit date, 6 months post quit date, end of pregnancy and at 6 months postpartum, validated using the exhaled carbon monoxide (CO) or urinary cotinine 2. Urge to smoke, measured using behavioural questionnaire at the end of pregnancy and 6 months after the birth 3. Tobacco withdrawal symptoms, measured using behavioural questionnaire at end of pregnancy and 6 months after the birth 4. Self- confidence in stopping smoking, measured using behavioural questionnaire at end of pregnancy and 6 months after the birth 5. Self-reported depression, measured using questionnaire at end of pregnancy and 6 months after the birth 6. Fetal morbidity and mortality outcomes are prospectively collected: 6.1. Miscarriage 6.2. Stillbirth 6.3. Neonatal death 6.4. Birth weight 6.5. Estimated fetal weight at 32 weeks 6.6. Estimated fetal weight at 36 weeks 6.7. Spontaneous pre-term birth 6.8. Iatrogenic pre-term birth 6.9. Birth injury 6.10. Neonatal complication 6.11. Oxygen dependence 6.12. Admission to neonatal unit 6.13. Length of stay of neonate 7. Maternal morbidity and mortality outcomes are prospectively collected: 7.1. Maternal death 7.2. Mode of delivery 7.3. Need for induction/delivery 7.4. Maternal need for intensive care 7.5. Maternal length of stay 7.6. Pre-eclampsia 7.7. Pregnancy induced hypertension 7.8. Postpartum haemorrhage 7.9. Blood transfusion 7.10. Late maternal complication 8. Satisfaction with results of care, measured using questionnaire in postnata | — |
Countries
Ireland
Outcome results
None listed