Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women

NCT02246114 | Terminated Results

• 1 other identifier: STUDY00000370
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant women. Investigators hypothesize that more regular self-monitoring, text messages and feedback as provided by home carbon monoxide monitoring device combined with medical feedback on results will reduce smoking during pregnancy compared to only receiving text message and no self-monitoring by home monitoring device and no feedback by home carbon monoxide monitoring device . The periconceptual period is a life period, where given the immediacy of the fetus and future child, a pregnant woman is willing to try and modify potentially harmful behaviors.

Conditions

Pregnancy; Smoking; Smoking Cessation

Keywords

Pregnancy; Smoking; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• Primary Outcome of Serum Cotinine Levels

  The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.

  1 year

Study Arms (2)

no CO monitor

EXPERIMENTAL

Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.

Other: Text messages

CO monitor

EXPERIMENTAL

Given a piCO+ Smokerlyzer® monitor, will receive daily text messages, will receive feedback about the relative level of carbon monoxide.

Device: piCO+ Smokerlyzer® monitor; Other: Text messages

Interventions

piCO+ Smokerlyzer® monitor DEVICE

CO monitor

Text messages OTHER

CO monitor; no CO monitor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women 18-40 years old
• Participants will be pregnant women estimated to be between 6 and 20 weeks into their pregnancy
• Pregnant women have smoked at least at least one cigarette in the prior 7 days
• Own a smartphone capable of delivering and receiving text messages

You may not qualify if:

• Project materials and text messages are in English, potential participants will be excluded if they cannot read English and if there are concerns about the ability to comprehend or comply with study procedures

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Penn State University: collaborator

Study Sites (1)

MS Hershey Medical Center, Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Limitations and Caveats

The study closed early due to lack of recruitment. Only 1 subject enrolled in the study and she terminated after the baseline visit due to a miscarriage at 9 weeks. Therefore no analysis has been performed.

Results Point of Contact

• Title: Richard S. Legro, M.D.
• Organization: The Milton S. Hershey Medical Center

rsl1@psu.edu

717-531-6210

Study Officials

• Richard S Legro, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 22, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

US (1)