Cessation, SmokingGESTABACNCT01872156
Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women
A study testing Intervention GESTABAC in people with Cessation, Smoking, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cessation, Smoking
- What is being tested?
- Intervention GESTABAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Jul 2017
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- pregnant at 20 weeks or less of gestation
- attending her first prenatal visit with any of the participating prenatal care teams (this first prenatal visit takes place usually around 6-12 weeks of pregnancy)
- defining herself as a current cigarette smoker or recent ex-smoker (see below for a definition of these terms)
- being able to meet the requisites of the trial:
- being available for the next 15 months
Show all 9Show fewer
- defining herself as fluent in reading and speaking Spanish to understand the study procedures and to comply with them
- meeting no exclusion criterion; and
- willing and able to give informed consent for participation in the study
Who cannot join
- communication barrier;
- active addictions to other psychoactive substances
- involved in any other formal smoking cessation program or in another trial during the study period; or
- does not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits.
Read the detailed description
Aim: To evaluate the efficiency of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on tobacco abstinence at the conclusion of the pregnancy self referred and validated with cooximetry.
Secondary objectives:
- To evaluate the effectiveness of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on the tobacco abstinence 6 months after the childbirth.
- The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.
- To study the effectiveness of the intervention in smoking on the maintenance of the breast-feeding to 3 and 6 months.
Method:
Design: cluster randomized controlled trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service.
Sample size adjusted for design effect: number of smoking women in every branch would be of 350.
- Conditions
- Cessation, Smoking
- Being tested
- Intervention GESTABAC, Control Group
- Keywords
- Smoking, Primary care
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GESTABACOther
Intervention based on the "Clinician's Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth.
Control GroupOther
The group control will act according to usual management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention GESTABAC | Experimental | Intervention based on the "Clinician's Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth. Receives: Other: Intervention GESTABAC |
| Control Group | Other | The group control will act according to usual management. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of abstinence of tobacco
Rate of abstinence of tobacco to 20-28 weeks of childbearing , to 36-38 weeks and to 6 postpartum (post-childbearing) months. The abstinence will be validated for cooximetry.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cessation, SmokingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Encarnación Serrano-Serrano, MD, Principal investigator, Gerencia de Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872156
- Sponsor's protocol ID
- SOMAMFYC11/2012
- Acronym
- GESTABAC
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2013
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention in Primary Care to Promote Smoking Cessation in Pregnant Women: Cluster Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01872156
- Acronym / sponsor ID
- GESTABAC / SOMAMFYC11/2012
- Conditions
- Cessation, Smoking
- Keywords
- Smoking, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Jun 2013 (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.
The purpose of this study is to evaluate the effectiveness of the behavior treatment accompanied by self-help materials in Primary health care, across the intervention of the midwifes in the pregnancy follow-up visits.
Detailed description
Aim: To evaluate the efficiency of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on tobacco abstinence at the conclusion of the pregnancy self referred and validated with cooximetry.
Secondary objectives:
- To evaluate the effectiveness of an intervention in smoking based on a clinical practice guideline on the part of the primary care professionals on the tobacco abstinence 6 months after the childbirth.
- The effectiveness of the intervention values on the weight of the newborn child, the number of childbirths pre-term and the perinatal mortality.
- To study the effectiveness of the intervention in smoking on the maintenance of the breast-feeding to 3 and 6 months.
Method:
Design: cluster randomized controlled trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service.
Sample size adjusted for design effect: number of smoking women in every branch would be of 350.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention GESTABAC | Experimental | Other: Intervention GESTABACIntervention based on the "Clinician's Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth. |
| Control Group | Other | Other: Control GroupThe group control will act according to usual management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- pregnant at 20 weeks or less of gestation
- attending her first prenatal visit with any of the participating prenatal care teams (this first prenatal visit takes place usually around 6-12 weeks of pregnancy)
- defining herself as a current cigarette smoker or recent ex-smoker (see below for a definition of these terms)
- being able to meet the requisites of the trial:
Key exclusion criteria (4 listed)
- communication barrier;
- active addictions to other psychoactive substances
- involved in any other formal smoking cessation program or in another trial during the study period; or
- does not consent to participate in the study
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 |
|---|---|---|
| Intervention GESTABACIntervention based on the "Clinician's Guide to helping Pregnant Women Quit Smoking" on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth. | Other | Intervention GESTABAC |
| Control GroupThe group control will act according to usual management. | Other | Control Group |
Primary outcome
Rate of abstinence of tobacco
Time frame: 6 months
Rate of abstinence of tobacco to 20-28 weeks of childbearing , to 36-38 weeks and to 6 postpartum (post-childbearing) months. The abstinence will be validated for cooximetry.
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 14 Aug 2017.
- An online platform to facilitate communication and dissemination of information between the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Encarnación Serrano-Serrano, MD principal investigator
Gerencia de Atención Primaria, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention GESTABAC in people with Cessation, Smoking, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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 9 inclusion and 4 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Rate of abstinence of tobacco (time frame: 6 months). 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 14 Aug 2017.