LaborNCT03752021

The Endocannabinoid System in Human Gestational Tissues in Labor

An observational study of Labor, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Labor
What is being tested?: Myometrial Sampling
Type of treatment: Surgery or procedure
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 25 Jan 2019to 1 Jul 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: * A total of 20 subjects will be enrolled in the pilot study * 10 laboring subjects * 10 non-laboring subjects

Who may be able to join

Pregnant women ages > 18 years old
Pregnant women 22 weeks, 0 days through 42 weeks, 0 days gestation undergoing cesarean section
Singleton gestation

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

Read the 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.

Conditions: Labor
Being tested: Myometrial Sampling
Keywords: Endocannabinoid System, Human Gestational Tissues, Labor, Cesarean Section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myometrial SamplingProcedure or surgery
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

Study groups in NCT03752021
Study group	Role	What they receive
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). Receives: Procedure: Myometrial Sampling
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) Receives: Procedure: Myometrial Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Presence of CB1 receptor protein
Identification of CB1 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Measured: At the time of C-section
Presence of CB2 receptor protein
Identification of CB2 receptor protein interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Measured: At the time of C-section
Presence of cannabinoid receptor
Identification of cannabinoid receptor interacting protein (CRIP) in gestational membranes, placenta, and myometrium
Measured: At the time of C-section
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.
Measured: At the time of C-section
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.
Measured: At the time of C-section
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.
Measured: At the time of C-section

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20191 Jul 2019

First posted23 Nov 2018
Study start25 Jan 2019
Primary completion1 Jul 2019
Study completion1 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for LaborStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03752021
Sponsor's protocol ID: IRB00051905
Status last verified: Jun 2019
First submitted: 21 Nov 2018
Last updated: 15 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 26808195
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.
PubMed 18177778
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.
PubMed 2165569
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.
PubMed 1700516
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.
PubMed 11279117
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.
PubMed 11106792
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.
PubMed 7753807
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.
PubMed 9108127
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.
PubMed 12505701
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.
PubMed 14749627
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.
PubMed 12744923
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.
PubMed 18833324
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.
PubMed 15531501
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.
PubMed 24324206
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.
PubMed 22639355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Endocannabinoid System in Human Gestational Tissues in Labor
ClinicalTrials.gov ID: NCT03752021
Acronym / sponsor ID: IRB00051905
Conditions: Labor
Keywords: Endocannabinoid System, Human Gestational Tissues, Labor, Cesarean Section
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 25 Jan 2019 (actual)
Primary completion: 1 Jul 2019 (actual)
Study completion: 1 Jul 2019 (actual)
First posted: 23 Nov 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Laboring Subjects	–	Procedure: Myometrial SamplingSubjects 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).
Non Laboring Subjects	–	Procedure: Myometrial SamplingSubjects 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)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: * A total of 20 subjects will be enrolled in the pilot study * 10 laboring subjects * 10 non-laboring subjects

Key inclusion criteria (3 listed)

Pregnant women ages > 18 years old
Pregnant women 22 weeks, 0 days through 42 weeks, 0 days gestation undergoing cesarean section
Singleton gestation

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Myometrial SamplingA 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	Procedure or surgery	Laboring Subjects, Non Laboring Subjects

Primary outcome

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
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
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
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
Background: PubMed 26808195Navathe 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.
Background: PubMed 18177778Goldenberg 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.
Background: PubMed 2165569Matsuda 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.
Background: PubMed 1700516Howlett 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.
Background: PubMed 11279117Paria 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.
Background: PubMed 11106792Paria 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.
Background: PubMed 7753807Das 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.
Background: PubMed 9108127Schmid 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.
Background: PubMed 12505701Paria 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.
Background: PubMed 14749627Dennedy 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.
Background: PubMed 12744923Park 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.
Background: PubMed 18833324Wang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa L Kozakiewicz, MD principal investigator

Wake Forest University Health Sciences

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Labor, run by Wake Forest University Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of CB1 receptor protein (time frame: At the time of C-section). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03752021, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.