Trial Outcomes & Findings for Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women (NCT NCT02246114)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

1 year

Results posted on

2017-01-16

Reasons for withdrawal
Measure	Arm A no CO monitor	Arm B CO monitor
Overall Study miscarriage	1	0

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

Baseline characteristics by cohort
Measure	Arm A n=1 Participants no CO monitor	Arm B CO monitor	Total n=1 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	—	32 years n=5 Participants
Gender Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants

Timeframe: 1 year

Population: Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.

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

Outcome data not reported

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Arm A (no CO Monitor) n=1 participants at risk no CO monitor	Arm B (CO Monitor) CO monitor
General disorders headache	100.0% 1/1 • Number of events 1	— 0/0

The Milton S. Hershey Medical Center

Phone: 717-531-6210