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

• Sponsor: University of Nottingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02125370
• Collaborator: (none)
• Enrollment: 15
• Locations: 2
• Duration (Months): 8
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Qualitative; Nicotine Replacement Therapy; Pregnancy	Other: Qualitative and survey

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Time Perspective: Cross-Sectional
• Official Title: Experiences of Pregnant Women Who Use NRT in Pregnancy as Part of a Quit Attempt
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Nicotine Replacement Therapy	Other: Qualitative and survey

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of women who adhere to NRT [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nottingham	Nottingham	Nottinghamshire	United Kingdom	NG7 2RD
2	New Leaf Stop smoking services	Nottingham		United Kingdom

Sponsors and Collaborators

• University of Nottingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT02125370
• Other Study ID Numbers: 14024
• First Posted: Apr 29, 2014
• Last Update Posted: Dec 4, 2014
• Last Verified: Dec 1, 2014

Study Results

No Results Posted as of Dec 4, 2014