Thomas Jefferson UniversitySidney Kimmel Medical College

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MOTHER Databases

Please review the MOTHER User’s Guide prior to downloading data.

Note: clicking on the database name will initiate download of a zip file containing the SPSS 18.0 database, codebook, and frequency distribution files

Screening Teleforms

S1 –    Initial Screening Basic intake information
S2 –    Participant Information Basic intake information
S3 –   
S4 –   
Eligibility Determination/ 
Medical Clearance
Summary of patient eligibility for study participation
S5 –    Medical History Past and current medical conditions
S6 –   Psychiatric Assessment Administration of the MINI and DSM IV SCID module E
S9 –   Nicotine Dependence Administration of the Faegstrom Test for Nicotine Dependence
S10 – Adjective Checklist Symptom checklist completed 3-4 days following receipt of study medication. 
S11 – Global Assessment Scale Drug satisfaction questionnaire completed 3-4 days following receipt of study medication
S12 – Drug Dose Adequacy  Drug dose questionnaire completed 3-4 days following receipt of study medication
S13 – Risk Behaviors Patient self-report on frequency of high risk behaviors during previous 30 days
S14 – OB Visit Obstetrical information at intake
S16 – CINA Narcotic withdrawal assessment administered every 6 hours during receipt of morphine
S21 – Lab Results Screening lab test results

Pre-Delivery Teleforms

PRE1ab.
PRE2ab –
Medication Blinding Administered to patient and staff at week 2 of study participation and 35 weeks EGA
PRE3 – Global Assessment Scale Drug satisfaction questionnaire administered weekly prior to delivery
PRE4 – Drug Dose Adequacy Drug dose questionnaire administered weekly prior to delivery
PRE7 – Adjective Checklist Symptom checklist administered weekly prior to delivery
PRE8 – Dose Change Request Administered weekly prior to delivery
PRE11 – Risk Behaviors Participant self-report on frequency of risk behaviors in prior 30 day period
PRE12 – OB Visit Data from participant prenatal appointments
PRE13 – Biophysical Profile Data from biophysical non-stress test conducted at 32 weeks EGA
PRE14 – CINA Narcotic withdrawal assessment administered every 6 hours during stabilization on double-blind study medication

Post-Delivery Teleforms

POST1 – NAS Assessment for neonatal abstinence syndrome completed on infant for a minimum of 10 days following birth
POST1 – NAS
(Aggregate)
Presence or absence of specific NAS symptoms and peak scores
POST2 – Nursery Environment Summary of nursery environment at time of NAS assessment
POST3 – Medication Blinding Questionnaire completed by NAS rater nurses
POST5 – Mother and Infant Delivery Delivery and birth data
POST9 – Participant Termination Information on termination of study participation
POST10 – NAS Gold Standard Scoring NAS assessment scores of certified raters

Ancillary Databases

Adverse Events:
S17 – Adverse Events
(Screening)
 
PRE6/
PRN1 –
Adverse Events 
(Mother
)
Pre-delivery and postpartum
PRN5 – Adverse Events
(Infant)
 
Addiction Severity Index (ASI): 
 S7 – Addiction Severity Index (Screening) ASI administered during screening
PRE9 – Addiction Severity Index (Pre-delivery) Follow-up ASI administered every 30 days
Concomitant Medications:
S15 – Concomitant Medications Mother 
(Screening)
Information on termination of study participation
PRE5/POST8/
PRN2 –
Concomitant Medications Mother 
(Pre and Post-Delivery)
NAS assessment scores of certified raters
PRN4 – Concomitant Medications
(Infant)
Concomitant medications given to infant
Additional Information:
Pharmacy Summary Data Data on morphine and double-blind study medication dosing
Drug Use Summary Summary of urine drug screen analysis results
Lab Results Aggregate Blood chemistry and liver function tests administered every 4 wks during pregnancy and 1x postpartum
Randomization Table Medication condition assignment (methadone or buprenorphine)
Voucher Summary Data Summary of monetary incentives earned during study participation