Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

Pregnancy Related Clinical Trial

— Q-PRONTO  

Official title:

Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888962
• Other study ID #: STUDY20060069
• Status: Completed
• Start date: June 14, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Pregnancy Related

Intervention

Other:
• OUD
History of opioid use disorder.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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