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Completed

NCT Number: NCT03752021

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.

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Key information

Conditions

Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 23, 2018
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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