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OpenTrials
Completed

NCT Number: NCT03442530

Tobacco Use in Pregnancy Intervention for Cessation

The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky College of Nursing

Lexington, Kentucky, 40536, United States

About this study

The purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (American College of Obstetricians and Gynecologists (ACOG) 5 A's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. This Tobacco use in Pregnancy Intervention for Cessation (ToPIC) will involve training the identified healthcare provider to become a Certified Tobacco Treatment Specialist (CTTS) and to administer the 5 A's to pregnant Medicaid patients receiving prenatal care through two high-volume Kentucky obstetrics clinics. This trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice.

The Investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. Eligible participants will be randomized to the intervention (ToPIC) or standard of care for smoking cessation in pregnancy. This pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. Furthermore, the Investigators' use of Medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. This study has the potential to significantly impact the most vulnerable in Kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant
  • tobacco user
  • able to read and write English
  • Medicaid eligible

Exclusion criteria

  • male

Treatment and study plan

ToPIC

Behavioral

Expanded tobacco cessation counseling for pregnant women.

Tobacco Treatment As Usual (TTAU)

Behavioral

Standard of care tobacco cessation counseling for pregnant women

Primary outcomes

  1. Smoking cessation

    Time frame: Baseline to third trimester

    Change in urine cotinine level

Secondary outcomes

  1. Number of cigarettes per day

    Time frame: Baseline to third trimester

    Self-reported change in number of cigarettes smoked per day

  2. Smoking cessation after delivery

    Time frame: Prior to delivery hospitalization discharge, estimated 3 days

    Self-report smoking cessation

  3. Infant birth weight

    Time frame: At time of delivery

    Infant weight measured in grams

  4. Gestational age

    Time frame: At time of delivery

    Weeks of gestation at delivery

  5. Health care utilization outside of well-visits

    Time frame: Birth to 6 months

    Maternal and infant visits for non-routine healthcare

Sponsors and collaborators

Lead sponsor

Kristin Ashford

Other

Collaborators

  • University of Kentucky

Registry information

Acronym: ToPIC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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