QualitativeNCT02125370
Experiences of Pregnant Women Who Use NRT in Pregnancy as Part of a Quit Attempt
An observational study of Qualitative and Nicotine Replacement Therapy, run by University of Nottingham at 2 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Qualitative, Nicotine Replacement Therapy, Pregnancy
- What is being tested?
- Qualitative and survey
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Nottingham
Nottingham, Nottinghamshire, NG7 2RD
New Leaf Stop smoking services
Nottingham
About this study
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.
- Conditions
- Qualitative, Nicotine Replacement Therapy, Pregnancy
- Being tested
- Qualitative and survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative and surveyOther
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Replacement Therapy | Not described Receives: Other: Qualitative and survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 4 weeks of taking part in the study
Secondary outcomes (1)
Number of women who adhere to NRT
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QualitativeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125370
- Sponsor's protocol ID
- 14024
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of Pregnant Women Who Use NRT in Pregnancy as Part of a Quit Attempt
- ClinicalTrials.gov ID
- NCT02125370
- Acronym / sponsor ID
- 14024
- Conditions
- Qualitative, Nicotine Replacement Therapy, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Replacement Therapy | – | Other: Qualitative and survey |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Quantitative survey;
- 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)
Key exclusion criteria (3 listed)
- Survey and qualitative interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative and survey | Other | Nicotine Replacement Therapy |
Primary outcome
number of women that use NRT after being prescribed
Time frame: 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.
1 secondary outcome
Number of women who adhere to NRT
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Qualitative and Nicotine Replacement Therapy, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of women that use NRT after being prescribed (time frame: within 4 weeks of taking part in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.