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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Opioid-use Disorder
• Intervention / Treatment: Other: OUD

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.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QST Pain threshold	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Grace Lim, MD, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY20060069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No