- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04888962
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
QST Pain threshold
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Grace Lim, MD, MS, University of Pittsburgh
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY20060069
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Kliniske studier på Graviditetsrelatert
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringSkrumplever, lever | HELLP syndrom | Intrahepatisk kolestase ved graviditet | Graviditetssykdom | AFLP - Acute Fatty Liver of PregnancyStorbritannia
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-
Yale UniversityNational Institute on Drug Abuse (NIDA)Rekruttering
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Biomedical Development CorporationFullførtOpioidbruksforstyrrelseForente stater
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HealthPartners InstituteNational Institute on Drug Abuse (NIDA); Hennepin Healthcare Research InstituteFullførtSelvmord | Opioidbruk | OpioidbruksforstyrrelseForente stater
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Women's College HospitalFullførtTilgang til primærhelsetjenestenCanada
-
University of Colorado, DenverNational Institute on Drug Abuse (NIDA)RekrutteringOpioidbruksforstyrrelseForente stater
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HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy...Påmelding etter invitasjonHIV-infeksjoner | Opioidbruk | Narkotika bruk | OpioidbruksforstyrrelseForente stater