Labor
Conditions
Keywords
Endocannabinoid System, Human Gestational Tissues, Labor, Cesarean Section
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.
Interventions
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
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 CB2 receptor protein | At the time of C-section | Identification of CB2 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. |
| 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. |
Countries
United States
Outcome results
None listed