An interventional study of Prescribed opioids in Pregnancy, Cesarean Section and Prescriptions, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Prescribed opioids
Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge
Pain Management and Opioid Usage Measured by Telephone Questionnaire
Outpatient opioid selection and use after discharge
Time frame: Within 2 weeks postpartum
| Milestone | Post-cesarean Delivery Mothers |
|---|---|
| Started | 51 |
| Completed | 50 |
| Not completed | 1 |
| Withdrew: Met exclusion criteria (postop los>7d) | 1 |
Outpatient opioid selection and use after discharge
| number of oxycodone 5mg tablets | Massachusetts General Hospital |
|---|---|
| Number of oxycodone tablets selected | 20.0 (15.0 to 25.0) |
| Number of oxycodone tablets dispensed | 20.0 (20.0 to 30.0) |
| Number of oxycodone tablets used | 15.5 (8.0 to 25.0) |
| Number of oxycodone tablets remaining | 4.0 (0 to 8.0) |
Collected over 2 weeks for each participant, as this was the timing of the post-discharge phone call. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Post-cesarean Delivery Mothers | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Massachusetts General Hospital |
|---|---|
| Median | 33.0 (29.0 to 37.0) |
| Sex: Female, Male(Participants) | Massachusetts General Hospital |
|---|---|
| Female | 50 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Massachusetts General Hospital |
|---|---|
| White | 27 |
| Black | 0 |
| Hispanic | 8 |
| Asian | 14 |
| Other | 1 |
| Type of cesarean delivery(Participants) | Massachusetts General Hospital |
|---|---|
| Primary | 35 |
| Repeat | 15 |
| Timing of cesarean delivery(Participants) | Massachusetts General Hospital |
|---|---|
| Planned | 19 |
| Unplanned | 31 |
| Postoperative length of stay(days) | Massachusetts General Hospital |
|---|---|
| Median | 4.0 (3.8 to 4.4) |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital