A Phase 4 interventional study of Gabapentin and Placebo in Opioid Use, Postpartum Disorder and Chronic Pain Syndrome, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.
A small percent of the large population of women who give birth have difficulty with prolonged pain, opioid use and poor functional recovery. This may be the first opiate exposure and significant health challenge in a young woman's life.
In our previous work, we have identified 20% who are at highest risk for prolonged pain and delayed opioid cessation and functional recovery with usual care. Moderate to severe pain on postpartum day 1 is a significant predictor of being in the risk group. The optimal intervention to mitigate this risk is unknown.
We plan to test an intervention of low dose gabapentin or placebo to be escalated by a pain medicine doctor as needed. We hypothesize that additional care of women predicted to be higher need by virtue of their postoperative day one pain score (> 6 x2) despite usual multimodal analgesic care will lead to reduced need for opioid, less pain and more rapid functional recovery.
40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.
This study's enrollment of 78 is close to the median of 81 across 32 interventional studies indexed under Puerperal Disorders.
Browse Puerperal Disorders studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Drug: Gabapentin
Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Drug: Placebo
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
Also known as: Active
Placebo to match gabapentin
Time to Opioid Cessation as a Measure of Opioid Utilization
Time frame: Up to 12 weeks
Pain Report
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
Time frame: 12 weeks
Functional Recovery
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
Time frame: 12 weeks
Fatigue
PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
Depression
PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
Anxiety
PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
PROMIS Physical Function
PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks after delivery
Steps
Fitness tracker measured steps
Time frame: 12 weeks after delivery
Sleep
Fitness tracker measured sleep
Time frame: 12 weeks after delivery
Heart Rate
Fitness tracker measured heart rate
Time frame: 12 weeks after delivery
| Milestone | Gabapentin | Control |
|---|---|---|
| Started | 41 | 37 |
| Received allocated intervention | 41 | 37 |
| Completed | 35 | 34 |
| Not completed | 6 | 3 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Discontinued intervention | 3 | 1 |
| weeks | Gabapentin | Control |
|---|---|---|
| Time to Opioid Cessation as a Measure of Opioid Utilization | 2 (1 to 4) | 2 (1 to 3) |
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
| weeks | Gabapentin | Control |
|---|---|---|
| Pain Report | 7 (5 to 12) | 12 (6 to 12) |
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
| weeks | Gabapentin | Control |
|---|---|---|
| Functional Recovery | 8 (5 to 12) | 11 (6 to 12) |
PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Results for this outcome have not been posted.
PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Results for this outcome have not been posted.
PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Results for this outcome have not been posted.
PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Results for this outcome have not been posted.
Fitness tracker measured steps
Results for this outcome have not been posted.
Fitness tracker measured sleep
Results for this outcome have not been posted.
Fitness tracker measured heart rate
Results for this outcome have not been posted.
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Control | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 37 | 78 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Female | 41 | 37 | 78 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 11 | 25 |
| Not Hispanic or Latino | 27 | 26 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| African American | 0 | 2 | 2 |
| Asian | 12 | 13 | 25 |
| Caucasian | 15 | 13 | 28 |
| Pacific Islander | 1 | 0 | 1 |
| Other | 10 | 7 | 17 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(Participants) | Gabapentin | Control | Total |
|---|---|---|---|
| United States | 41 | 37 | 78 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2018 to primary completion in Jul 2020, 21 months.
Results were first posted in Nov 2021, 1 year 4 months after primary completion.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin