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Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD (Q-PRONTO)

4. oktober 2021 opdateret af: Grace Lim, MD, MS, University of Pittsburgh

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

13

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.
Andet: OUD
History of opioid use disorder.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
QST Pain threshold
Tidsramme: Completed at a time point antepartum/ before delivery
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
Tidsramme: Completed at a time point antepartum/ before delivery
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
Tidsramme: 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 they first feel pain
Completed within 24 hours postpartum/ after delivery
QST Pain Tolerance
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Efterforskere

  • Ledende efterforsker: Grace Lim, MD, MS, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juni 2021

Primær færdiggørelse (Faktiske)

30. september 2021

Studieafslutning (Faktiske)

30. september 2021

Datoer for studieregistrering

Først indsendt

11. maj 2021

Først indsendt, der opfyldte QC-kriterier

11. maj 2021

Først opslået (Faktiske)

17. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY20060069

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Graviditetsrelateret

Kliniske forsøg med OUD

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner