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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
INTERVENTION: Women who smoke in pregnancy are randomised at first visit to either the STOP clinic or a pre‐defined 'routine care'. In the STOP clinic, they have consultant led antenatal care with the addition of a dedicated smoking cessation practitioner who is in‐built into the clinic. As smokers are at risk of late‐onset intrauterine growth restriction (IUGR) they are scanned at 32 and 36 weeks gestation. 300 women are assigned to the intervention arm and 300 to pre‐defined 'routine care' ‐ 150 of the routine care group receive the additional scans at 32 and 36 weeks, and 150 who do not receive any additional scans. Smoking status is biologically quantified and measured at each visit. They receive smoking cessation reviews at booking visit, one week post quit date, 4 weeks, three months and six months/end of pregnancy. A final cessation status is recorded in the postnatal period. CONDITION: Smoking in pregnancy ; Pregnancy and Childbirth ; Smoking in pregnancy PRIMARY OUTCOME: 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 OUTCOME: 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 postnatal period; 9. Confidence as an active participant in health care decisions, measured using questionnaire in postnatal period; 10. Confidence in healthcare providers, measured using questionnaire in postnatal period; 11. Birth experience, measured using questionnaire in postnatal period INCLUSION CRITERIA: 1. = 18yrs old 2. Singleton pregnancy 3. Smoking = 1 cigarette daily 4. English language spoken
Epistemonikos ID: f27569122237e834762bb54334d27536ff522d37
First added on: Aug 24, 2024