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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
QST Pain threshold
Tidsram: 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
Tidsram: 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
|
|
QST Pain Threshold
Tidsram: 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
|
Completed within 24 hours postpartum/ after delivery
|
|
QST Pain Tolerance
Tidsram: Completed within 24 hours postpartum/ after delivery
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Grace Lim, MD, MS, University of Pittsburgh
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY20060069
Plan för individuella deltagardata (IPD)
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