Smoking, Nicotine and Pregnancy 3 Trial

Not Applicable

• Conditions: Smoking in pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN84798566
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-13
• Last Update Posted: 3 June 2024
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1430

Inclusion Criteria

Current inclusion criteria as of 08/03/2022:

Women of any age who:
1. Are <25 weeks’ gestation and have been referred for or have received or attended an intment as part of standard antenatal care
2. Smoke = 5 daily cigarettes
3. Willing to set a quit date and accept referral to SSS
4. Willing to use NRT patch to try to stop smoking
5. Able to understand written and spoken English
6. Able to give consent

_____

Previous inclusion criteria:

Women of any age who:
1. Are =25 weeks’ gestation with dating ultrasound-confirmed pregnancies
2. Smoke =5 daily cigarettes
3. Willing to set a quit date and accept referral to SSS
4. Are willing to use an NRT patch to try to stop smoking
5. Able to give consent

Exclusion Criteria

Current exclusion criteria as of 21/11/2023:
1. Already in a cessation study
2. Contraindications to NRT including: known severe reaction/hypersensitivity to NRT, recent cardiovascular/cerebrovascular event or changes and taking theophylline/clozapine
3. Currently uses e-cigarette every day or more frequently

Previous exclusion criteria:
1. Already in a cessation study
2. Currently uses e-cigarettes daily or more frequently
3. Contraindications to NRT including: severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or transient ischaemic attack (TIA), chronic, generalized skin disorders or sensitivity to nicotine patches, chemical dependence/alcohol addiction or major fetal anomalies
4. Not able to read or understand text written in English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemically validated, prolonged abstinence from smoking self-reported between 6 weeks after randomisation and 36 weeks gestation or childbirth, whichever is earlier. Biochemical validation: cotinine/anabasine levels in saliva sample and/or CO levels tested using CO monitor. Timepoint: 36 weeks gestation or at childbirth, whichever is the soonest.