Double-blind, randomised, placebo-controlled trial of nicotine replacement therapy in pregnancy

Completed

Conditions: Pregnancy/Childbirth
Pregnancy and Childbirth
Smoking in pregnancy

Registration Number: ISRCTN07249128

Lead Sponsor: niversity of Nottingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1050

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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:<br>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<br>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 Outcome Measures