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

NCT ID: NCT02125370

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Qualitative Nicotine Replacement Therapy Pregnancy

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Nicotine Replacement Therapy

Qualitative and survey

Intervention Type OTHER

Interventions

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Qualitative and survey

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Nottingham

Nottingham, Nottinghamshire, United Kingdom

Site Status

New Leaf Stop smoking services

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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14024

Identifier Type: -

Identifier Source: org_study_id