- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
QST Pain threshold
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Grace Lim, MD, MS, University of Pittsburgh
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY20060069
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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