The Endocannabinoid System in Human Gestational Tissues in Labor

Completed

• Conditions: Labor
• Interventions: Procedure: Myometrial Sampling

• 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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laboring Subjects	Myometrial Sampling	Subjects with a planned cesarean delivery who labor prior to their scheduled date or those who are in labor and require an unplanned but non-emergent cesarean delivery. These subjects will be approached upon admission to the study facility by the researcher for potential enrollment to allow adequate time to consider participation, ask questions, provide consent, and prior to procedure (Myometrial Sampling).
Non Laboring Subjects	Myometrial Sampling	Subjects with a planned cesarean delivery will be approached by the researcher during prenatal visits or at the study facilities prior to planned procedure (Myometrial Sampling)

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