Clinical trial NCT03752021: The Endocannabinoid System in Human Gestational Tissues in Labor
Official title: The Endocannabinoid System in Human Gestational Tissues in Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor
Keywords: Endocannabinoid System
Human Gestational Tissues
Labor
Cesarean Section
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * A total of 20 subjects will be enrolled in the pilot study
* 10 laboring subjects
* 10 non-laboring subjects

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of CB1 receptor protein
timeFrame: At the time of C-section
measure: Presence of CB2 receptor protein
timeFrame: At the time of C-section
measure: Presence of cannabinoid receptor
timeFrame: At the time of C-section
measure: Levels of CB1 receptor protein
timeFrame: At the time of C-section
measure: Levels of CB2 receptor protein
timeFrame: At the time of C-section
measure: Levels of cannabinoid receptor
timeFrame: At the time of C-section
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Melissa L Kozakiewicz, MD
role: PRINCIPAL_INVESTIGATOR
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