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This is a prospective observational case-control study comparing quantitative sensory testing data preformed during the third trimester of pregnancy and within 24 hours postpartum in women on medication-assisted treatment for opioid use disorder (OUD) to a gestational age-controlled cohort of women who do not have OUD.
The primary goal is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.
The objective of this study is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.
The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort group | This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until 24 hours postpartum. |
| |
| Control group | This cohort will include pregnant patients without a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until 24 hours postpartum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OUD | Other | History of opioid use disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QST Pain threshold | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain | Completed at a time point antepartum/ before delivery |
| QST Pain Tolerance | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable. | Completed at a time point antepartum/ before delivery |
| QST Pain Threshold | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain | Completed within 24 hours postpartum/ after delivery |
| QST Pain Tolerance | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable. | Completed within 24 hours postpartum/ after delivery |
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Inclusion Criteria:
Subjects that will be included in the prospective cohort group:
Patients who will be included in the control group:
Exclusion Criteria:
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This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Lim, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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