Experiences of Pregnant Women Who Use NRT in Pregnancy as Part of a Quit Attempt

Completed

• Conditions: Pregnancy; Qualitative; Nicotine Replacement Therapy
• Interventions: Other: Qualitative and survey

• Registration Number: NCT02125370
• Lead Sponsor: University of Nottingham

Brief Summary

This study is largely a qualitative study with a small survey component. The aim of the survey would be to gain a quantitative perspective of how women use NRT after this has been prescribed by stop smoking services (SSS). The aim of the qualitative study would be to enhance knowledge of pregnant smoker's views and attitudes about their experiences of using NRT and in particular to understand why pregnant women who start using NRT often discontinue this early or do not use the medication as it is prescribed. This information is important for a number of reasons; firstly it will help health professionals and researchers gain an in depth understanding about how women experience using NRT, which may be used to help devise strategies for encouraging better adherence and which could be used in future clinical trials to gain a clearer understanding as to whether or not NRT is effective in pregnancy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Quantitative survey;

  • Women who are pregnant
  • Aged 16 or over (no upper age limit)
  • Who have been prescribed NRT (patches/dual therapy) to aid a quit attempt.

Qualitative interview study will include the above plus;

• Women will have used NRT for over 24 hours
• Either not be using NRT as prescribed (as deciphered by the survey questions) or have currently quit NRT (and have either stopped smoking or continue to smoke)

Exclusion Criteria

• Survey and qualitative interviews

  • Women who cannot understand the study procedure sufficiently in order to provide consent e.g. due to cognitive difficulties
  • Women who are unable to read or understand the consent procedure and study procedures in English.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy	Qualitative and survey	-

Primary Outcome Measures

Name	Time	Method
number of women that use NRT after being prescribed	within 4 weeks of taking part in the study	All women will be asked whether they have used NRT after being given a prescription, this measurement will be obtained within 4 weeks of the participant consenting to take part in the study.

Secondary Outcome Measures

Name	Time	Method
Number of women who adhere to NRT	4 weeks

Trial Locations

Locations (2)

New Leaf Stop smoking services; 🇬🇧 Nottingham, United Kingdom

University of Nottingham; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom