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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125370
• Other study ID #: 14024
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: December 3, 2014
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Nicotine Replacement Therapy
• Pregnancy
• Qualitative

Intervention

Other:
• Qualitative and survey

Locations

Country	Name	City	State
United Kingdom	New Leaf Stop smoking services	Nottingham
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of women that use NRT after being prescribed	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.	within 4 weeks of taking part in the study	No
Secondary	Number of women who adhere to NRT		4 weeks	No