PregnancyNCT02770612
Shared Decision Making for Prescription Opioids After Cesarean Delivery
A study testing Prescribed opioids in people with Pregnancy and Cesarean Section, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Cesarean Section, Prescriptions
- What is being tested?
- Prescribed opioids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postpartum women who underwent a cesarean delivery at MGH
Who cannot join
- Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
- Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
- Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
- Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
- Women with impaired decision-making abilities
- Women hospitalized for > 7 days related to CD
Show all 9Show fewer
- Minors (<18 years old)
- Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
- Women with contraindications to taking acetaminophen or NSAIDs
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.
- Conditions
- Pregnancy, Cesarean Section, Prescriptions, Analgesics, Opioid
- Being tested
- Prescribed opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescribed opioidsOther
Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge
| Study group | Role | What they receive |
|---|---|---|
| Post-cesarean delivery mothers | Other | 1. Identify eligible women on post-operative day 3. A physician member of the study team will approach participants with study information and consent forms.
2. After informed consent is obtained, the participant will be taken through a 10 minute shared decision making session (intervention). The participant will then have the opportunity to ask questions, following which they will indicate the number of prescription opioid tablets to be discharged with (primary outcome)
3. The next contact will be at two weeks after discharge, at which time a member of the study team will contact the participant and administer a brief telephone survey with questions pertaining to perceived pain over time, pain management methods, opioid/pain medication consumption/disposal, and satisfaction with postoperative pain control.
4. A chart review will be performed by physicians in the research group on participants to gather information on demographics, indications for surgery, etc. Receives: Other: Prescribed opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Management and Opioid Usage Measured by Telephone Questionnaire
Outpatient opioid selection and use after discharge
Measured: Within 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Bateman, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770612
- Sponsor's protocol ID
- 2016P000251
- Status last verified
- Mar 2019
- First submitted
- 9 May 2016
- Last updated
- 7 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
PubMed 28594762
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Prescription Opioids After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02770612
- Acronym / sponsor ID
- 2016P000251
- Conditions
- Pregnancy, Cesarean Section, Prescriptions, Analgesics, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 7 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-cesarean delivery mothers | Other | Other: Prescribed opioids1. Identify eligible women on post-operative day 3. A physician member of the study team will approach participants with study information and consent forms. 2. After informed consent is obtained, the participant will be taken through a 10 minute shared decision making session (intervention). The participant will then have the opportunity to ask questions, following which they will indicate the number of prescription opioid tablets to be discharged with (primary outcome) 3. The next contact will be at two weeks after discharge, at which time a member of the study team will contact the participant and administer a brief telephone survey with questions pertaining to perceived pain over time, pain management methods, opioid/pain medication consumption/disposal, and satisfaction with postoperative pain control. 4. A chart review will be performed by physicians in the research group on participants to gather information on demographics, indications for surgery, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postpartum women who underwent a cesarean delivery at MGH
Key exclusion criteria (9 listed)
- Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
- Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
- Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
- Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
- Women with impaired decision-making abilities
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 |
|---|---|---|
| Prescribed opioidsMaking a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge | Other | Post-cesarean delivery mothers |
Primary outcome
Pain Management and Opioid Usage Measured by Telephone Questionnaire
Time frame: Within 2 weeks postpartum
Outpatient opioid selection and use after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28594762Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
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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?
A study testing Prescribed opioids in people with Pregnancy and Cesarean Section, run by Massachusetts General Hospital 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 1 inclusion and 9 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 7 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Management and Opioid Usage Measured by Telephone Questionnaire (time frame: Within 2 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02770612, which also lists 1 linked publication.
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 7 Mar 2019.