The Endocannabinoid System in Human Gestational Tissues in Labor
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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Winston-Salem、North Carolina、アメリカ、27103
- Novant Health Forsyth Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
- A total of 20 subjects will be enrolled in the pilot study
- 10 laboring subjects
- 10 non-laboring subjects
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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 |
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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Presence of CB1 receptor protein
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Melissa L Kozakiewicz, MD、Wake Forest University Health Sciences
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB00051905
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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