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The Endocannabinoid System in Human Gestational Tissues in Labor

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ClinicalTrials.gov Identifier: NCT03752021
Recruitment Status : Completed
First Posted : November 23, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment
Labor Procedure: Myometrial Sampling

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Endocannabinoid System in Human Gestational Tissues in Labor
Actual Study Start Date : January 25, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Group/Cohort Intervention/treatment
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).
Procedure: Myometrial 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


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)
Procedure: Myometrial 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





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.


Biospecimen Retention:   Samples Without DNA
A sample of the uterus will be removed at the existing incision made by your doctors. The uterine segment (sample) will be 2 inches in length and 0.5 inches in width. The placenta and the attached membranes will also be collected for the study. The uterine incision will be repaired in the standard fashion.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752021


Locations
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United States, North Carolina
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Melissa L Kozakiewicz, MD Wake Forest University Health Sciences
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03752021    
Other Study ID Numbers: IRB00051905
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Endocannabinoid System
Human Gestational Tissues
Labor
Cesarean Section