The Endocannabinoid System in Human Gestational Tissues in Labor

Labor Clinical Trial

Official title:

The Endocannabinoid System in Human Gestational Tissues in Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752021
• Other study ID #: IRB00051905
• Status: Completed
• Start date: January 25, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor

Intervention

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

Locations

Country	Name	City	State
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (19)

Chioss G, Costantine MM, Bytautiene E, Betancourt A, Hankins GD, Saade GR, Longo M. In vitro myometrial contractility profiles of different pharmacological agents used for induction of labor. Am J Perinatol. 2012 Oct;29(9):699-704. doi: 10.1055/s-0032-1314891. Epub 2012 May 29. — View Citation

Chiossi G, Costantine MM, Bytautiene E, Kechichian T, Hankins GD, Sbrana E, Saade GR, Longo M. The effects of prostaglandin E1 and prostaglandin E2 on in vitro myometrial contractility and uterine structure. Am J Perinatol. 2012 Sep;29(8):615-22. doi: 10.1055/s-0032-1311986. Epub 2012 May 25. — View Citation

Costa MA, Fonseca BM, Keating E, Teixeira NA, Correia-da-Silva G. 2-arachidonoylglycerol effects in cytotrophoblasts: metabolic enzymes expression and apoptosis in BeWo cells. Reproduction. 2014 Feb 3;147(3):301-11. doi: 10.1530/REP-13-0563. Print 2014 Mar. — View Citation

Das SK, Paria BC, Chakraborty I, Dey SK. Cannabinoid ligand-receptor signaling in the mouse uterus. Proc Natl Acad Sci U S A. 1995 May 9;92(10):4332-6. — View Citation

Dennedy MC, Friel AM, Houlihan DD, Broderick VM, Smith T, Morrison JJ. Cannabinoids and the human uterus during pregnancy. Am J Obstet Gynecol. 2004 Jan;190(1):2-9; discussion 3A. — View Citation

Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4. Review. — View Citation

Habayeb OM, Taylor AH, Evans MD, Cooke MS, Taylor DJ, Bell SC, Konje JC. Plasma levels of the endocannabinoid anandamide in women--a potential role in pregnancy maintenance and labor? J Clin Endocrinol Metab. 2004 Nov;89(11):5482-7. — View Citation

Howlett AC, Bidaut-Russell M, Devane WA, Melvin LS, Johnson MR, Herkenham M. The cannabinoid receptor: biochemical, anatomical and behavioral characterization. Trends Neurosci. 1990 Oct;13(10):420-3. Review. — View Citation

Luckas MJ, Wray S. A comparison of the contractile properties of human myometrium obtained from the upper and lower uterine segments. BJOG. 2000 Oct;107(10):1309-11. — View Citation

Matsuda LA, Lolait SJ, Brownstein MJ, Young AC, Bonner TI. Structure of a cannabinoid receptor and functional expression of the cloned cDNA. Nature. 1990 Aug 9;346(6284):561-4. — View Citation

Moynihan AT, Smith TJ, Morrison JJ. The relaxant effect of nifedipine in human uterine smooth muscle and the BK(Ca) channel. Am J Obstet Gynecol. 2008 Feb;198(2):237.e1-8. doi: 10.1016/j.ajog.2007.08.074. — View Citation

Navathe R, Berghella V. Tocolysis for Acute Preterm Labor: Where Have We Been, Where Are We Now, and Where are We Going? Am J Perinatol. 2016 Feb;33(3):229-35. doi: 10.1055/s-0035-1571147. Epub 2016 Jan 25. Review. — View Citation

Paria BC, Dey SK. Ligand-receptor signaling with endocannabinoids in preimplantation embryo development and implantation. Chem Phys Lipids. 2000 Nov;108(1-2):211-20. Review. — View Citation

Paria BC, Song H, Wang X, Schmid PC, Krebsbach RJ, Schmid HH, Bonner TI, Zimmer A, Dey SK. Dysregulated cannabinoid signaling disrupts uterine receptivity for embryo implantation. J Biol Chem. 2001 Jun 8;276(23):20523-8. Epub 2001 Mar 8. — View Citation

Paria BC, Wang H, Dey SK. Endocannabinoid signaling in synchronizing embryo development and uterine receptivity for implantation. Chem Phys Lipids. 2002 Dec 31;121(1-2):201-10. Review. — View Citation

Park B, Gibbons HM, Mitchell MD, Glassa M. Identification of the CB1 cannabinoid receptor and fatty acid amide hydrolase (FAAH) in the human placenta. Placenta. 2003 May;24(5):473-8. Corrected and republished in: Placenta. 2003 Nov;24(10):990-5. — View Citation

Quenby S, Matthew A, Zhang J, Dawood F, Wray S. In vitro myometrial contractility reflects indication for caesarean section. BJOG. 2011 Nov;118(12):1499-506. doi: 10.1111/j.1471-0528.2011.03064.x. Epub 2011 Jul 27. — View Citation

Schmid PC, Paria BC, Krebsbach RJ, Schmid HH, Dey SK. Changes in anandamide levels in mouse uterus are associated with uterine receptivity for embryo implantation. Proc Natl Acad Sci U S A. 1997 Apr 15;94(8):4188-92. — View Citation

Wang H, Xie H, Dey SK. Loss of cannabinoid receptor CB1 induces preterm birth. PLoS One. 2008 Oct 3;3(10):e3320. doi: 10.1371/journal.pone.0003320. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of CB1 receptor protein	Identification of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium	At the time of C-section
Primary	Presence of CB2 receptor protein	Identification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium	At the time of C-section
Primary	Presence of cannabinoid receptor	Identification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium	At the time of C-section
Primary	Levels of CB1 receptor protein	Quantification of levels of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.	At the time of C-section
Primary	Levels of CB2 receptor protein	Quantification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.	At the time of C-section
Primary	Levels of cannabinoid receptor	Quantification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium. A statistical comparison between groups will be performed.	At the time of C-section