Trial · NCT03918850
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Illicit Opioid-negative Urine Samples During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Illicit Opioid-negative Urine Samples Postpartum | Delivery through 12 months postpartum | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. |
| Secondary | Percentage of Days With Study Medication Adherence During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Days With Study Medication Adherence - Postpartum | Delivery through 12 months postpartum | Adherence to treatment from delivery through 12 months postpartum, checked weekly. |
| Secondary | Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase | Delivery through 12 months postpartum | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine. |
| Secondary | Opioid Craving Scale - Pregnancy | Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery | The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported. |
| Secondary | Opioid Craving Scale - Postpartum | Assessed at months 1, 3, 6, 9, and 12 post-delivery | The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported |
| Secondary | Adequacy of Prenatal Care Utilization Index | At delivery | The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants. |
| Secondary | Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy | Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery | Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported. |
| Secondary | Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum | Assessed at months 1, 3, 6, 9, and 12 post-delivery | Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported. |
| Secondary | Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms | Neonate discharge from hospital, typically within 1 month postpartum | Use of opioid medication for NOWS symptoms will be abstracted from the medical record. |
| Secondary | Total Days of Neonatal Opioid Treatment During the Hospital Stay | Neonate discharge from hospital, typically within 1 month postpartum | Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record. |
| Secondary | Infant Hospital Length of Stay | Neonate discharge from hospital, typically within 1 month postpartum | Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants) |
| Secondary | Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score | Neonate discharge from hospital, typically within 1 month postpartum | NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal. |
| Secondary | Custody at Discharge | Neonate discharge from hospital, typically within 1 month postpartum | For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage. |
| Secondary | Child Protective Services Open Case | Neonate discharge from hospital, typically within 1 month postpartum | Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services. |
| Secondary | Ages and Stages Questionnaire, Third Edition (ASQ-3) | 12 months postpartum | To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03918850/registered