OBSERVATIONALCOMPLETEDNCT03752021
The Endocannabinoid System in Human Gestational Tissues in Labor
The purpose of this research study is to determine if the endocannabinoid (a biological system) plays a role in the labor process.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2019-08-15
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- Not reported
- Enrollment
- 20 (ACTUAL)
- Start date
- 2019-01-25
- Sponsor
- Wake Forest University Health Sciences
- Design
- Not reported
- Locations
- 2
- Results record
- Not present in registry snapshot
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.
LaborEndocannabinoid SystemHuman Gestational TissuesLaborCesarean Section
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
PROCEDUREMyometrial Sampling
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
Eligibility
Population and criteria
- Sex
- FEMALE
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Healthy volunteers
- Accepted
Study population
* A total of 20 subjects will be enrolled in the pilot study * 10 laboring subjects * 10 non-laboring subjects
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
primary measures
Presence of CB1 receptor protein
Time frame: At the time of C-section
Identification of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Presence of CB2 receptor protein
Time frame: At the time of C-section
Identification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Presence of cannabinoid receptor
Time frame: At the time of C-section
Identification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Levels of CB1 receptor protein
Time frame: 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
Time frame: 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.
Levels of cannabinoid receptor
Time frame: 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.
Publications
Locally readable linked articles
background referencePLoS ONE · Free full text Snapshot provenance
- Snapshot
- e1e5f245-9d86-485e-9220-2ea6180e4a99
- Retrieved
- 11/09/2026, 14:15:29
- SHA-256
- 7990e914e47d420fc7eed886a1eea9806ddd7c6231b604edc81e01111faeb036