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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246114
• Other study ID #: STUDY00000370
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: May 14, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Smoking
• Smoking Cessation

Intervention

Device:
• piCO+ Smokerlyzer and text messages
Arm B: will be given a piCO+ Smokerlyzer® monitor, will receive daily text messages, and will receive feedback about the relative level of carbon monoxide.

Other:
• Text messages
Arm A: not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.

Locations

Country	Name	City	State
United States	MS Hershey Medical Center, Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary outcome CO levels versus cotinine levels	Secondary outcome is the correlation between CO levels and cotinine levels.	1 year	No