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

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ClinicalTrials.gov Identifier: NCT02246114
Recruitment Status : Terminated (Lack of Recruitment)
First Posted : September 22, 2014
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Pregnancy Smoking Smoking Cessation Device: piCO+ Smokerlyzer® monitor Other: Text messages Not Applicable

Detailed Description:
Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease and cancer risk, has proven remarkably difficult in traditional medical practice settings, and successful medical trials have been costly and labor intensive. This proposal aims to utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation among pregnant women who smoke. Investigators hypothesize that women who have access to a self-monitoring device more frequently (i.e., at home) and receive feedback about their carbon monoxide level will have greater reductions in smoking as determined by declining serum cotinine levels over the course of the study compared to women who do not have access to a self-monitoring device and do not receive feedback about their carbon monoxide level, but only receive text messages.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: no CO monitor
Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.
Other: Text messages
Experimental: CO monitor
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



Primary Outcome Measures :
  1. Primary Outcome of Serum Cotinine Levels [ Time Frame: 1 year ]
    The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246114


Locations
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United States, Pennsylvania
MS Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State University
Investigators
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Principal Investigator: Richard S Legro, MD Penn State College of Medicine

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Responsible Party: Richard S. Legro, M.D., Professor of Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02246114     History of Changes
Other Study ID Numbers: STUDY00000370
First Posted: September 22, 2014    Key Record Dates
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017
Last Verified: November 2016
Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Pregnancy
Smoking
Smoking cessation
Additional relevant MeSH terms:
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Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs