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Completed Not applicable Interventional Accepts healthy volunteers

Preventing Postpartum Return to Smoking

ClinicalTrials.gov ID: NCT00917943

Public ClinicalTrials.gov record NCT00917943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 13, 2026, 8:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Smoking Resumption-Prevention is Postpartum Women

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption. A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points. 1. Between 28 and 34 weeks of pregnancy 2. 6-weeks postpartum 3. 6-months postpartum 4. 12-months postpartum Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes: 1. One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum. 2. Risk profiles will be used to match the intervention to each woman's needs. 3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care. We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill NC area and Fayetteville NC.

Study identification

NCT ID
NCT00917943
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Duke University
Other
Enrollment
386 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2008
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012
Last update posted
Apr 9, 2013

2008 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Duke University Medical Center Durham North Carolina 27705

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00917943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 9, 2013 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00917943 live on ClinicalTrials.gov.

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