The Endocannabinoid System in Human Gestational Tissues in Labor

Completed

• Conditions: Labor

• Registration Number: NCT03752021
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this research study is to determine if the endocannabinoid (a biological system) plays a role in the labor process.

Detailed Description

This is a pilot study to determine the feasibility of identification and quantification of various components of the endocannabinoid system in the labored versus non-labored myometrium, placenta and gestational membranes.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2019-01-25
• Status Verified: 2019-06
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Pregnant women ages > 18 years old
• Pregnant women 22 weeks, 0 days through 42 weeks, 0 days gestation undergoing cesarean section
• Singleton gestation

Exclusion Criteria

• Cannabinoid use during pregnancy
• Illicit drug use during pregnancy
• Nonsteroidal anti-inflammatory drug use within 7 days of cesarean section
• Maternal comorbidities including pre-existing diabetes, pre-existing hypertension, hypertensive disorders of pregnancy (preeclampsia, eclampsia), epilepsy currently being treated with antiepileptic medication, intraamniotic infection
• Uterine abnormalities
• Fetal anomalies
• Drug use or dependency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of CB1 receptor protein	At the time of C-section	Identification of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Presence of cannabinoid receptor	At the time of C-section	Identification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Levels of CB1 receptor protein	At the time of C-section	Quantification of levels of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.
Levels of CB2 receptor protein	At the time of C-section	Quantification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.
Presence of CB2 receptor protein	At the time of C-section	Identification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Levels of cannabinoid receptor	At the time of C-section	Quantification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.

Trial Locations

Locations (2)

Novant Health Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States