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

University of Pittsburgh

Status: Completed

Conditions: Opioid-use Disorder; Pregnancy Related

Treatments: Other: OUD

Study type: Observational

Funder types: Other

Identifiers

NCT04888962

STUDY20060069

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

13 participants in 2 patient groups

Prospective cohort group

Description:

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.

Treatment:

Other: OUD

Control group

Description:

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.