---
title: The Endocannabinoid System in Human Gestational Tissues in Labor
nct_id: NCT03752021
overall_status: COMPLETED
sponsor: Wake Forest University Health Sciences
study_type: OBSERVATIONAL
primary_condition: Labor
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03752021.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03752021"
ct_last_update_post_date: 2019-08-15
last_seen_at: "2026-05-12T06:39:15.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Endocannabinoid System in Human Gestational Tissues in Labor

**NCT ID:** [NCT03752021](https://clinicaltrials.gov/study/NCT03752021)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Wake Forest University Health Sciences
- **Conditions:** Labor
- **Start Date:** 2019-01-25
- **Completion Date:** 2019-07-01
- **CT.gov Last Update:** 2019-08-15

## 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

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **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
```

## Arms

- **Laboring Subjects** — 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).
- **Non Laboring Subjects** — 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)

## Interventions

- **Myometrial Sampling** (PROCEDURE) — 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

## Primary Outcomes

- **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.

## Locations (2)

- Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States
- Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novant health forsyth medical center|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `locations.wake forest university health sciences|winston-salem|north carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03752021.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03752021*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*