Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD (Q-PRONTO)
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Subjects that will be included in the prospective cohort group:
- individuals at least 18 years of age
- at least 28 weeks gestation (third trimester)
- on medication-assisted treatment for opioid use disorder, including methadone or suboxone.
Patients who will be included in the control group:
- individuals at least 18 years of age
- at least 28 weeks gestation (third trimester)
- have not been on been on opioids in the past 12 months.
Exclusion Criteria:
- Those who are unable to participate in informed consent discussions,
- Unable to give informed consent for any reason,
- Not fluent in English (surveys are validated in English language)
- Unable to participate fully in all study procedures for any reason including sensory deficits, scar tissue, or infection at any QST sites.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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History of opioid use disorder.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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QST Pain threshold
大体时间：Completed at a time point antepartum/ before delivery
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Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
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Completed at a time point antepartum/ before delivery
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QST Pain Tolerance
大体时间：Completed at a time point antepartum/ before delivery
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Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.
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Completed at a time point antepartum/ before delivery
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QST Pain Threshold
大体时间：Completed within 24 hours postpartum/ after delivery
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Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain
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Completed within 24 hours postpartum/ after delivery
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QST Pain Tolerance
大体时间：Completed within 24 hours postpartum/ after delivery
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Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.
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Completed within 24 hours postpartum/ after delivery
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合作者和调查者
调查人员
- 首席研究员：Grace Lim, MD, MS、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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