CClinicalTrials.gg
CompletedNCT02125370Updated Dec 4, 2014

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

An observational study in Qualitative, Nicotine Replacement Therapy and Pregnancy, sponsored by University of Nottingham. Completed at 2 sites in United Kingdom. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-04.

Sponsored by University of Nottingham · Observational

Study type
Observational
Time perspective
Cross-sectional
Enrollment
15
Ages
16 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Qualitative
  • Nicotine Replacement Therapy
  • Pregnancy
03

In context

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be identified through two identification sites; New Leaf Stop Smoking Services in Nottinghamshire and Nottingham City. The study will consist of a short survey focussing on how NRT is used during pregnancy. As well as providing information the survey responses will also be able to distinguish who is eligible to participate in qualitative telephone interviews. A subsection of these women will be asked to participate in an interview. The survey and interviews will be conducted as close as possible after participants have had an appointment with a smoking cessation advisor and, have given consent for the researcher to contact them, this is likely to be within a two week period.

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

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.
05

Study design

Time perspective
Cross-sectional
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Nicotine Replacement Therapy

    Other: Qualitative and survey

Interventions

  • OtherQualitative and survey
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 4 weeks of taking part in the study

Secondary outcomes

  1. Number of women who adhere to NRT

    Time frame: 4 weeks

07

Study locations

2 sites
  • University of Nottingham
    Nottingham, Nottinghamshire NG7 2RD, United Kingdom
  • New Leaf Stop smoking services
    Nottingham, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02125370
Lead sponsor
University of Nottingham
Responsible party
Sponsor
First posted
Apr 29, 2014
Start date
Apr 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 4, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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