Pregnancy/Childbirth Pregnancy and Childbirth Smoking in pregnancy
Conditions
Interventions
Treatment group:
Pregnant women will receive an eight week course of 15 mg/16 hour NRT transdermal patches. Although many studies have used longer courses, there is no evidence that these are more ef
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Eligible women are women between 12 and 24 weeks pregnant 2. Report smoking at least ten cigarettes daily before pregnancy 3. Still currently smoke at least five cigarettes daily 4. An exhaled Carbon Monoxide (CO) reading above 8 ppm
Exclusion criteria
Exclusion criteria: Women with the following contraindications to the use of NRT will be excluded: 1. Severe cardiovascular disease 2. Unstable angina 3. Cardiac arrhythmias 4. Recent cerebrovascular accident or Transient Ischaemic Attack (TIA) 5. Chronic generalised skin disorders or known sensitivity to nicotine patches 6. Chemical dependence/alcohol addiction problems 7. Women who cannot give informed consent and those with known major foetal anomalies will also be excluded Intra-Uterine Growth Restriction (IUGR) is not an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported, prolonged and total abstinence from smoking or the use of any non-pharmacological nicotine containing substances between a quit date set within two weeks of randomisation and immediately prior to childbirth. Prolonged abstinence cannot be comprehensively validated, but if participants report prolonged abstinence and are abstinent at both time points below, they will be considered to have a positive primary outcome: 1. Self reported smoking cessation for at least 24 hours before follow-up at one month after quit date, validated by exhaled Carbon Monoxide measurement 2. Self reported smoking cessation for at least 24 hours before hospital admission for childbirth, validated by exhaled Carbon Monoxide or salivary cotinine measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Smoking: 1.1. Self reported, prolonged abstinence from smoking between quit date and one month 1.2. Self reported, prolonged abstinence from smoking between quit date and 6 months after delivery 1.3. Self reported smoking cessation for previous 7 day period at 6 months after delivery (point prevalence) 1.4. Self reported, prolonged abstinence from smoking between quit date and 2 years after delivery 1.5. Self reported smoking cessation for previous 7 day period at 2 years after delivery (point prevalence) 2. Foetal loss and morbidity: 2.1. Foetal death and stillbirth 2.2. Neonatal death (i.e. from birth to 28 days) 2.3. Post-neonatal death (29 days to 2 years) 2.4. Individualised birth weight Z score (i.e. birth weight adjust for gestational age, maternal height, maternal weight at booking and ethnic group) 2.5. Apgar score 2.6. Cord blood pH 2.7. Gestational age at birth 2.8. Intraventricular haemorrhage 2.9. Neonatal enterocolitis 2.10. Neonatal convulsions 2.11. Congenital abnormality 3. Maternal morbidity and mortality: 3.1. Maternal mortality 3.2. Mode of delivery 3.3. Proteinuria 3.4. Hypertension in pregnancy 4. Early childhood outcomes: 4.1. Behaviour and development at 2 years 4.2. Disability at 2 years 4.3. Respiratory symptoms at 2 years 5. Health economic data: 5.1. Duration of maternal hospital admission for childbirth 5.2. Duration of any admission (of baby) to special care 5.3. Health status at 6 months (EQ5D) | — |
Countries
United Kingdom
Outcome results
None listed