PregnancyPhase 3NCT00181909
Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
A Phase 3 study testing Smoking cessation counseling delivered by telephone in people with Pregnancy and Smoking Cessation, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Smoking Cessation
- What is being tested?
- Smoking cessation counseling delivered by telephone
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 434 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Jun 2005
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women
- current cigarette smoker (smoked >1 cigarette in the past 7 days)
- 18 years old or older
- Willing to consider altering their smoking behavior during their pregnancy
Who cannot join
- More than 26 weeks' gestation at study entry
- No telephone access
- Not planning to live in New England for 1 year
- Unable to read and speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Tufts Health Plan
Waltham, Massachusetts
About this study
The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.
Read the detailed description
A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (>50%) reduction in daily cigarette use.
- Conditions
- Pregnancy, Smoking Cessation
- Being tested
- Smoking cessation counseling delivered by telephone
- Keywords
- Pregnancy, Smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation counseling delivered by telephoneBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
Secondary outcomes (3)
Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
Self-reported significant (>50%) reduction in tobacco use
Quit attempt of >24 hours duration from enrollment to end of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2001
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Nancy A Rigotti, MD, Principal investigator, Massachusetts General HospitalElyse R Park, PhD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181909
- Sponsor's protocol ID
- 2000-P-002438
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 28 Nov 2006
- Results posted
- No
Publications
Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. doi: 10.1097/01.AOG.0000218100.05601.f8.
PubMed 16816060Park ER, Quinn VP, Chang Y, Regan S, Loudin B, Cummins S, Perry K, Rigotti NA. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. Prev Med. 2007 Mar;44(3):223-9. doi: 10.1016/j.ypmed.2006.10.008. Epub 2007 Jan 3.
PubMed 17204318
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
- ClinicalTrials.gov ID
- NCT00181909
- Acronym / sponsor ID
- 2000-P-002438
- Conditions
- Pregnancy, Smoking Cessation
- Keywords
- Pregnancy, Smoking cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Sep 2001
- Study completion
- Jun 2005
- First posted
- 16 Sep 2005 (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 principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.
Detailed description
A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (>50%) reduction in daily cigarette use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women
- current cigarette smoker (smoked >1 cigarette in the past 7 days)
- 18 years old or older
- Willing to consider altering their smoking behavior during their pregnancy
Key exclusion criteria (4 listed)
- More than 26 weeks' gestation at study entry
- No telephone access
- Not planning to live in New England for 1 year
- Unable to read and speak English
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 |
|---|---|---|
| Smoking cessation counseling delivered by telephone | Behavioural | – |
Primary outcome
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
3 secondary outcomes
Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
Self-reported significant (>50%) reduction in tobacco use
Quit attempt of >24 hours duration from enrollment to end of pregnancy
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 28 Nov 2006.
- Results publication: PubMed 16816060Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. doi: 10.1097/01.AOG.0000218100.05601.f8.
- Derived from this study: PubMed 17204318Park ER, Quinn VP, Chang Y, Regan S, Loudin B, Cummins S, Perry K, Rigotti NA. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. Prev Med. 2007 Mar;44(3):223-9. doi: 10.1016/j.ypmed.2006.10.008. Epub 2007 Jan 3.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Nancy A Rigotti, MD principal investigator
Massachusetts General Hospital
Elyse R Park, PhD study director
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Smoking cessation counseling delivered by telephone in people with Pregnancy and Smoking Cessation, run by Massachusetts General Hospital at 2 sites in United States.
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 4 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 28 Nov 2006. 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181909, which also lists 2 linked publications.
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 28 Nov 2006.