The Endocannabinoid System in Human Gestational Tissues in Labor
14 de agosto de 2019 actualizado por: Wake Forest University Health Sciences
The purpose of this research study is to determine if the endocannabinoid (a biological system) plays a role in the labor process.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
20
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Novant Health Forsyth Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
- A total of 20 subjects will be enrolled in the pilot study
- 10 laboring subjects
- 10 non-laboring subjects
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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).
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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 |
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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)
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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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Presence of CB1 receptor protein
Periodo de tiempo: At the time of C-section
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Identification of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
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At the time of C-section
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Presence of CB2 receptor protein
Periodo de tiempo: At the time of C-section
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Identification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
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At the time of C-section
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Presence of cannabinoid receptor
Periodo de tiempo: At the time of C-section
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Identification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium
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At the time of C-section
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Levels of CB1 receptor protein
Periodo de tiempo: At the time of C-section
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Quantification of levels of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium.
A statistical comparison between groups will be performed.
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At the time of C-section
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Levels of CB2 receptor protein
Periodo de tiempo: At the time of C-section
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Quantification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium.
A statistical comparison between groups will be performed.
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At the time of C-section
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Levels of cannabinoid receptor
Periodo de tiempo: At the time of C-section
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Quantification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium.
A statistical comparison between groups will be performed.
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At the time of C-section
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Melissa L Kozakiewicz, MD, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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. doi: 10.1038/346561a0.
- 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. doi: 10.1016/0166-2236(90)90124-s.
- 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. doi: 10.1074/jbc.M100679200. Epub 2001 Mar 8.
- 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. doi: 10.1016/s0009-3084(00)00197-3.
- 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. doi: 10.1073/pnas.92.10.4332.
- 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. doi: 10.1073/pnas.94.8.4188.
- 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. doi: 10.1016/s0009-3084(02)00156-1.
- 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. doi: 10.1016/j.ajog.2003.07.013.
- 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. doi: 10.1053/plac.2002.0926.
- 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.
- 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. doi: 10.1210/jc.2004-0681.
- 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.
- 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.
- 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.
- 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. doi: 10.1111/j.1471-0528.2000.tb11626.x.
- 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.
- 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.
- Kozakiewicz ML, Zhang J, Leone-Kabler S, Yamaleyeva LM, McDonald AG, Brost BC, Howlett AC. Differential Expression of CB1 Cannabinoid Receptor and Cannabinoid Receptor Interacting Protein 1a in Labor. Cannabis Cannabinoid Res. 2022 Jun;7(3):279-288. doi: 10.1089/can.2020.0107. Epub 2021 Apr 16.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de enero de 2019
Finalización primaria (Actual)
1 de julio de 2019
Finalización del estudio (Actual)
1 de julio de 2019
Fechas de registro del estudio
Enviado por primera vez
21 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de noviembre de 2018
Publicado por primera vez (Actual)
23 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB00051905
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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