Neonatal Abstinence SyndromeHOPENCT01889121
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers
An observational study of Neonatal Abstinence Syndrome, run by Dr. Henry Akinbi at 1 site in United States.
Trial summary
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Structured psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Opiate abusing pregnant women who received their prenatal care through Good Samaritan Faculty Medical Center and were getting methadone maintenance therapy
Who may be able to join
- Positive Methadone tox screen
- Received care at Good Samaritan Hospital in Cincinnati
- Delivered at Good Samaritan Hospital
Who cannot join
- Twin gestation
- Sever congenital anomalies
- Conditions requiring transfer to quaternary hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Structured psychosocial intervention
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured psychosocial interventionBehavioural
This is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention
| Study group | Role | What they receive |
|---|---|---|
| Methadone maintenance program | Mothers on methadone treatment at time of delivery who delivered at Good Samaritan Hospital but were not enrolled in psychosocial intervention offered through the HOPE (Helping Opiate-addicted Pregnant women Evolve) program. | |
| Psychosocial intervention | Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program). Receives: Behavioral: Structured psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome
Infants delivered to mothers that are maintained on methadone are at risk for neonatal abstinence syndrome. Psychosocial support is provided to pregnant women in methadone maintenance program to impact the outcome of the infants. The percentage of infants requiring pharmacotherapy would be expected to be reduced by the addition of psychosocial intervention to methadone maintenance program.
Measured: Birth until discharge
Secondary outcomes (3)
Gestational age at which the infants were delivered.
Addiction of pregnant women to opiate drugs is associated with preterm delivery. The gestational ages of infants delivered to women in the two groups will be compared for statistically significant differences.
Measured: Gestational age at delivery.
Percentage of infants that are small for gestational age.
Addiction to opiates is associated with fetal growth restriction. This study compared the proportion of infants who are <90th percentile for gestational age in both groups.
Measured: Gestional period.
Anthropometric measurements at birth
Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.
Measured: Measurements at birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Henry Akinbi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Henry Akinbi, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889121
- Sponsor's protocol ID
- HOPE_Methadone
- Acronym
- HOPE
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs
- ClinicalTrials.gov ID
- NCT01889121
- Acronym / sponsor ID
- HOPE / HOPE_Methadone
- Conditions
- Neonatal Abstinence Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Dr. Henry AkinbiUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone maintenance program | – | –Mothers on methadone treatment at time of delivery who delivered at Good Samaritan Hospital but were not enrolled in psychosocial intervention offered through the HOPE (Helping Opiate-addicted Pregnant women Evolve) program. |
| Psychosocial intervention | – | Behavioral: Structured psychosocial interventionPregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Opiate abusing pregnant women who received their prenatal care through Good Samaritan Faculty Medical Center and were getting methadone maintenance therapy
Key inclusion criteria (3 listed)
- Positive Methadone tox screen
- Received care at Good Samaritan Hospital in Cincinnati
- Delivered at Good Samaritan Hospital
Key exclusion criteria (3 listed)
- Twin gestation
- Sever congenital anomalies
- Conditions requiring transfer to quaternary hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured psychosocial interventionThis is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention | Behavioural | Psychosocial intervention |
Primary outcome
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome
Time frame: Birth until discharge
Infants delivered to mothers that are maintained on methadone are at risk for neonatal abstinence syndrome. Psychosocial support is provided to pregnant women in methadone maintenance program to impact the outcome of the infants. The percentage of infants requiring pharmacotherapy would be expected to be reduced by the addition of psychosocial intervention to methadone maintenance program.
3 secondary outcomes
Gestational age at which the infants were delivered.
Time frame: Gestational age at delivery.
Percentage of infants that are small for gestational age.
Time frame: Gestional period.
Anthropometric measurements at birth
Time frame: Measurements at birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Abstinence Syndrome, run by Dr. Henry Akinbi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome (time frame: Birth until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.