NCT03442530

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

January 30, 2018

Last Update Submit

March 23, 2020

Conditions

Pregnancy

Keywords

pregnancy, smoking cessation, tobacco, preterm birth, ToPIC

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Change in urine cotinine level

    Baseline to third trimester

Secondary Outcomes (5)

  • Number of cigarettes per day

    Baseline to third trimester

  • Smoking cessation after delivery

    Prior to delivery hospitalization discharge, estimated 3 days

  • Infant birth weight

    At time of delivery

  • Gestational age

    At time of delivery

  • Health care utilization outside of well-visits

    Birth to 6 months

Study Arms (2)

Tobacco Treatment As Usual (TTAU)

ACTIVE COMPARATOR

Eligible women assigned to the control group will be informed of the risks of tobacco use and benefits of quitting using the ACOG 5A's approach by their healthcare provider.5 This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The study coordinator will invite participants to complete the tobacco use questionnaires (TUQ),urine cotinine validation, and Expired Air Carbon Monoxide (EACO) analysis to assess ongoing tobacco use at the designated time points.

Behavioral: Tobacco Treatment As Usual (TTAU)

ToPIC

EXPERIMENTAL

Eligible women assigned to the intervention will receive TTAU plus ToPIC administered by the CTTS. At least once monthly, at routinely scheduled prenatal visits or through telephone, the CTTS will provide cessation counseling. The CTTS will invite participants to complete TUQs,urine cotinine validation and EACO analysis to assess ongoing tobacco use at the designated time points.

Behavioral: ToPIC

Interventions

ToPICBEHAVIORAL

Expanded tobacco cessation counseling for pregnant women.

ToPIC
Tobacco Treatment As Usual (TTAU)BEHAVIORAL

Standard of care tobacco cessation counseling for pregnant women

Tobacco Treatment As Usual (TTAU)

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsresearch participants must be pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky College of Nursing

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Smoking CessationPremature Birth

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kristin Ashford

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Dean of Undergraduate Faculty Affairs, University of Kentucky College of Nursing

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 22, 2018

Study Start

January 22, 2018

Primary Completion

February 15, 2019

Study Completion

February 15, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)