Trial · NCT01561079
Fetal and Infant Effects of Maternal Buprenorphine Treatment
NCT01561079, Phase 2, Phase 3, Completed, Johns Hopkins University; results first posted 2017-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fetal and Infant Effects of Maternal Buprenorphine Treatment. Trials, record NCT01561079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01561079
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fetal and Infant Effects of Maternal Buprenorphine Treatment
- NCT number
- NCT01561079
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 127 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Buprenorphine
- First posted
- 2012-03-22
- Last updated
- 2017-09-26
- Results first posted
- 2017-08-28
- Limitations and caveats
- Small sample size
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fetal Heart Rate | 24, 28, 32 and 36 weeks of gestation | Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels |
| Primary | Fetal Heart Rate Variability | 24, 28, 32 and 36 weeks of gestation | Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels |
| Primary | Accelerations of Fetal Heart Rate | 24, 28, 32 36 weeks of gestation | Number of accelerations of fetal heart rate exhibited during the 60 minute recordings |
| Primary | Fetal Movement | 24, 28, 32, 36 weeks of gestation | Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels |
| Primary | Fetal Movement - Fetal Heart Rate Coupling | 24, 28, 32, 36 weeks of gestation | The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fetal Heart Rate | 24, 28, 32 and 36 weeks of gestation | Participants active in the protocol at 24, 28, 32 and 36 weeks, respectively | beats per minute | MEAN |
| PRIMARY | Fetal Heart Rate Variability | 24, 28, 32 and 36 weeks of gestation | Per protocol | msec | MEAN |
| PRIMARY | Accelerations of Fetal Heart Rate | 24, 28, 32 36 weeks of gestation | accelerations | MEAN | |
| PRIMARY | Fetal Movement | 24, 28, 32, 36 weeks of gestation | seconds | MEAN | |
| PRIMARY | Fetal Movement - Fetal Heart Rate Coupling | 24, 28, 32, 36 weeks of gestation | percentage of time FM assoc w FHR change | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fetal Heart Rate | FHR 24 Weeks Trough | 145.7 | Standard Deviation 5.8 | beats per minute | |
| Fetal Heart Rate | FHR 28 Weeks Trough | 143.3 | Standard Deviation 5.4 | beats per minute | |
| Fetal Heart Rate | FHR 32 Weeks Trough | 138.6 | Standard Deviation 6.0 | beats per minute | |
| Fetal Heart Rate | FHR 36 Weeks Trough | 136.3 | Standard Deviation 7.1 | beats per minute | |
| Fetal Heart Rate | FHR 24 Weeks Peak | 143.9 | Standard Deviation 6.4 | beats per minute | |
| Fetal Heart Rate | FHR 28 Weeks Peak | 141.0 | Standard Deviation 4.8 | beats per minute | |
| Fetal Heart Rate | FHR 32 Peak | 135.4 | Standard Deviation 6.3 | beats per minute | |
| Fetal Heart Rate | FHR 36 Peak | 131.3 | Standard Deviation 6.1 | beats per minute | |
| Fetal Heart Rate Variability | FHRV 24 Trough | 5.4 | Standard Deviation 1.3 | msec | |
| Fetal Heart Rate Variability | FHRV 28 Trough | 6.7 | Standard Deviation 1.9 | msec |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Maternal Buprenorphine Treatment | 127 | |
| Overall Study | COMPLETED | Maternal Buprenorphine Treatment | 49 | |
| Overall Study | NOT COMPLETED | Maternal Buprenorphine Treatment | 78 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cholestasis of pregnancy | Hepatobiliary disorders | Maternal Buprenorphine Treatment | 3 | 49 | 3 |
| other | Bacterial vaginosis | Infections and infestations | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
| other | choroid plexus cysts | Nervous system disorders | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
| other | cardiomegaly | Cardiac disorders | Maternal Buprenorphine Treatment | 2 | 49 | 2 |
| other | pneumonia | Infections and infestations | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
| other | fetal growth restriction | General disorders | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
| other | chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Maternal Buprenorphine Treatment | 2 | 49 | 2 |
| other | Fetal stress at delivery | Pregnancy, puerperium and perinatal conditions | Maternal Buprenorphine Treatment | 2 | 49 | 2 |
| other | psychiatric concern | General disorders | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
| other | fetal arrythmia | Cardiac disorders | Maternal Buprenorphine Treatment | 1 | 49 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Maternal Buprenorphine Treatment | 0 | 49 |
| Total, other adverse events | Maternal Buprenorphine Treatment | 15 | 49 |
| Total, serious adverse events | Maternal Buprenorphine Treatment | 1 | 49 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01561079
GET https://conductscience.org/api/trials/v1/NCT01561079/results?page=2