The Endocannabinoid System in Human Gestational Tissues in Labor

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

Detailed Description
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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.

Official Title
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The Endocannabinoid System in Human Gestational Tissues in Labor

Conditions
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Labor

Intervention / Treatment
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* Procedure: Myometrial Sampling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laboring Subjects<br>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). | Procedure: Myometrial Sampling<br>* A myometrial sample will be obtained at the time of cesarean delivery. Sample will be obtained from the superior edge of the existing lower uterine segment incision and will be 2 inches in length and 0.5 inches in width. The uterine incision will be repaired in a standard two-layer closure. If a classical cesarean (vertical) uterine incision is deemed necessary and is performed by the surgical team, a sample of the same size will be taken parallel to the incision at the existing edge. The classical uterine incision will be closed utilizing the standard layered technique. Placenta and gestational membrane tissue will be obtained after placental delivery. The entire placenta and attached gestational membranes will be collected if not being sent for pathologic review<br>|
| Non Laboring Subjects<br>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) | Procedure: Myometrial Sampling<br>* A myometrial sample will be obtained at the time of cesarean delivery. Sample will be obtained from the superior edge of the existing lower uterine segment incision and will be 2 inches in length and 0.5 inches in width. The uterine incision will be repaired in a standard two-layer closure. If a classical cesarean (vertical) uterine incision is deemed necessary and is performed by the surgical team, a sample of the same size will be taken parallel to the incision at the existing edge. The classical uterine incision will be closed utilizing the standard layered technique. Placenta and gestational membrane tissue will be obtained after placental delivery. The entire placenta and attached gestational membranes will be collected if not being sent for pathologic review<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Endocannabinoid System, Human Gestational Tissues, Cesarean Section