The Endocannabinoid System in Human Gestational Tissues in Labor

Wake Forest University (WFU)

Status: Completed

Conditions: Labor

Treatments: Procedure: Myometrial Sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03752021

IRB00051905

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Laboring Subjects

Description:

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).

Treatment:

Procedure: Myometrial Sampling

Non Laboring Subjects

Description:

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)

Treatment:

Procedure: Myometrial Sampling