Trial Outcomes & Findings for Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment (NCT NCT00522626)

Results Overview

Fetal heart rate in beats per minute

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

60 minutes

Results posted on

2016-03-01

Enrollment occured between May 2006 and May 2009 from a drug treatment facility treating pregnant and postpartum drug dependent women

Participant milestones
Measure	Observational Opioid exposed pregnancies
Overall Study STARTED	19
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	Observational Opioid exposed pregnancies
Overall Study Lost to Follow-up	7

Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment

Baseline characteristics by cohort
Measure	Observational n=19 Participants Opioid exposed pregnancies
Age, Continuous	30.25 years STANDARD_DEVIATION 7.38 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

Timeframe: 60 minutes

Population: Total number of subjects completing assessment

Fetal heart rate in beats per minute

Outcome measures
Measure	Trough Fetal Heart Rate n=12 Participants Opioid exposed pregnancies
Fetal Heart Rate	142.34 beats per minute Standard Deviation 10.60

Timeframe: 120 minutes

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Johns Hopkins University School of Medicine

Phone: 410-550-5438