Opioid UsePhase 4NCT03472521
Prevention of Persistent Opioid Use in Mothers
A Phase 4 study testing Gabapentin in people with Opioid Use and Postpartum Disorder, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use, Postpartum Disorder, Chronic Pain Syndrome
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 10 Apr 2021
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Delivery within 5 days, able to provide informed consent, English speaker
Who cannot join
- Opiate use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94305
About this study
Official title: Prevention of Persistent Pain and Opioid Use in Mothers - POMS
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.
Read the detailed description
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.
- Conditions
- Opioid Use, Postpartum Disorder, Chronic Pain Syndrome
- Being tested
- Gabapentin, Placebo
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Active
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
PlaceboDrug
Placebo to match gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | 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. Receives: Drug: Gabapentin |
| Control | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Opioid Cessation as a Measure of Opioid Utilization
Measured: Up to 12 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start17 Sep 2018
- Primary completion2 Jul 2020
- Study completion10 Apr 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Flood, MD, MA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472521
- Sponsor's protocol ID
- IRB-43964
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2018
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Komatsu R, Carvalho B, Flood PD. Recovery after Nulliparous Birth: A Detailed Analysis of Pain Analgesia and Recovery of Function. Anesthesiology. 2017 Oct;127(4):684-694. doi: 10.1097/ALN.0000000000001789.
PubMed 28926443Komatsu R, Carvalho B, Flood P. Prediction of outliers in pain, analgesia requirement, and recovery of function after childbirth: a prospective observational cohort study. Br J Anaesth. 2018 Aug;121(2):417-426. doi: 10.1016/j.bja.2018.04.033.
PubMed 30032880Fowler C, Chu AW, Guo N, Ansari JR, Shafer SL, Flood PD. Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1122-1132. doi: 10.1213/ANE.0000000000006429. Epub 2023 Apr 12.
PubMed 37043404
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Persistent Pain and Opioid Use in Mothers - POMS
- ClinicalTrials.gov ID
- NCT03472521
- Acronym / sponsor ID
- IRB-43964
- Conditions
- Opioid Use, Postpartum Disorder, Chronic Pain Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Posted 4 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin 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. |
| Control | Placebo comparator | Drug: PlaceboMatched 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Delivery within 5 days, able to provide informed consent, English speaker
Key exclusion criteria (1 listed)
- Opiate use disorder
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 |
|---|---|---|
| GabapentinAlso: ActiveTreatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration. | Drug | Gabapentin |
| PlaceboPlacebo to match gabapentin | Drug | Control |
Primary outcome
Time to Opioid Cessation as a Measure of Opioid Utilization
Time frame: Up to 12 weeks
2 secondary outcomes
Pain Report
Time frame: 12 weeks
Functional Recovery
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28926443Komatsu R, Carvalho B, Flood PD. Recovery after Nulliparous Birth: A Detailed Analysis of Pain Analgesia and Recovery of Function. Anesthesiology. 2017 Oct;127(4):684-694. doi: 10.1097/ALN.0000000000001789.
- Background: PubMed 30032880Komatsu R, Carvalho B, Flood P. Prediction of outliers in pain, analgesia requirement, and recovery of function after childbirth: a prospective observational cohort study. Br J Anaesth. 2018 Aug;121(2):417-426. doi: 10.1016/j.bja.2018.04.033.
- Derived from this study: PubMed 37043404Fowler C, Chu AW, Guo N, Ansari JR, Shafer SL, Flood PD. Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1122-1132. doi: 10.1213/ANE.0000000000006429. Epub 2023 Apr 12.
- Individual participant dataSharing planned: No
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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.
Pamela Flood, MD, MA principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Opioid Use and Postpartum Disorder, run by Stanford University 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 1 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 5 May 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2021). 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?
Time to Opioid Cessation as a Measure of Opioid Utilization (time frame: Up to 12 weeks). 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 NCT03472521, which also lists 3 linked publications.
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 5 May 2022.