Clinical trial NCT04888962: Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD
Official title: Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Pregnancy Related
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: QST Pain threshold
timeFrame: Completed at a time point antepartum/ before delivery
measure: QST Pain Tolerance
timeFrame: Completed at a time point antepartum/ before delivery
measure: QST Pain Threshold
timeFrame: Completed within 24 hours postpartum/ after delivery
measure: QST Pain Tolerance
timeFrame: Completed within 24 hours postpartum/ after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: