Alterations of ECM in Umbilical Cord ECM in PreeclampisaNCT01931891
Extracellular Matrix Remodeling of the Umbilical Cord and Placenta in Preeclampsia
An observational study of Alterations of ECM in Umbilical Cord ECM in Preeclampisa and Alterations of ECM in Placenta in Preeclampisa, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not known, complex pathophysiologic pathways and mechanisms have been described. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alterations of ECM in Umbilical Cord ECM in Preeclampisa, Alterations of ECM in Placenta in Preeclampisa
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Jul 2014
- 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 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: preeclamptic women
Who may be able to join
- Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)
Who cannot join
- known chronic disease multipl pregnancies
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Hospital
Ankara
nuri danisman, md, 306-5000
ayse kirbas, md
About this study
Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not known, complex pathophysiologic pathways and mechanisms have been described.
New blood vessels evolve during angiogenesis and vasculogenesis, two physiological processes, that play a crucial role in embryogenesis and placentation. Structural alterations in the human umbilical cord, maternal spiral arteries can cause adverse fetal consequences.Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
Read more
Matrixmetalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various components of the extracellular matrix (ECM). A Disintegrin And Metalloproteinases (ADAMs) and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix Metalloproteinases (MMPs). Dysregulation of ADAMs and ADAMTS expression have been reported in different types of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation or asthma.
The role of ADAMTS in the pathomechanism of pre-eclampsia has not been studied until now. We therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from newborns of mothers with pre-eclampsia with those with normal pregnancy.
Read the detailed description
Preeclampsia is a multi-systemic disorder. Despite its seriousness, the aetyology remains unknown. Current theories include abnormal placentation, cardiovascular maladaptation to pregnancy, genetic and immune mechanisms, angiogenic factors and an enhanced systemic inflammatory response. Poor placental perfusion leading to wide spread maternal endothelial dysfunction is accepted as a major mechanism.
The trophoblastic invasion of maternal vessels results many changes in extracellular matrix, which gives rise to high uteroplacental vessel distensibility to accommodate the increased blood flow. So, İn normal pregnancy, there is a wide spread vasodilatation, with increased arterial compliance and reduced peripheral vascular resistance.In preeclampsia, however, trophoblastic invasion is reduced, leading to incomplete modification of maternal spiral arteries and therefore to decreases in placental perfusion.
Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord and placenta. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
Matrix metalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various components of the extracellularmatrix (ECM). These enzymes play an essential role in physiological states such as tissue remodeling, morphogenesis and wound healing anda lso in pathological processes such as tumor cell invasion and metastasis.
A Disintegrin And Metalloproteinases (ADAMs) and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix Metalloproteinases (MMPs). Dysregulation of ADAMsexpression has beenreported in differenttypes of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation or asthma.
Some authors suggestted that ADAM-8, -9, -10, -12, -15, -17, and ADAMTS-1 might play roles in uterus remodeling during the periimplantation period and ADAMTS-12, independent of its proteolytic activity, plays a critical role in human trophoblastic cell invasion in vitro.
Human umbilical cord is an extra-embryonic structure linking the mother and fetus during pregnancy In the umbilical cord two arteries and one vein are surrounded by a collagen-rich, myxomatous substance, called Wharton's jelly (WJ) that protect the umbilical vessels against extension, bending, twisting and compression.
The extracellular matrix (ECM) of WJ is very copious and contains significant amounts of hyaluronic acid and some sulphated glycosaminoglycans (GAGs). İts interesting that Wharton's jelly contain a low number of cells but large amounts of collagen and GAGs. Wharton's jelly plays also an important role as a storage for some compounds, such as growth factor. Previous studies demonstrated that both human umbilical cord serum and tissues contain large amounts of IGF-I and IGF-binding proteins (BPs), mainly BP-1 and BP-3.
Structural alterations in the human umbilical cord can cause adverse fetal consequences. ECM dynamics can result from changes of ECM composition, for example, because of altered synthesis or degradation of one or more ECM components, or in architecture because of altered organization. Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord.
İt found that significant increase in collagen content in the umbilical cord arteries and vein and premature replacement of hyaluronic acid by sulfated GAGs both in the UCAs and in Wharton's jelly in preeclampsia. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
The role of ADAMTS in the pathology of pre-eclampsia has not been studied until now. We therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from newborns of mothers with pre-eclampsia with those with normal pregnancy.
- Conditions
- Alterations of ECM in Umbilical Cord ECM in Preeclampisa, Alterations of ECM in Placenta in Preeclampisa
- Keywords
- preeclampsia, ADAMTS , wharton jelly, extracellüler matrix, placenta
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prreclampsia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe preclampsia
Measured: 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alterations of ECM in Umbilical Cord ECM in PreeclampisaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turgut Ozal University
- Responsible party
- Principal investigator, Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- ayse kirbas, md, Principal investigator, zekai tahir burak hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931891
- Sponsor's protocol ID
- ztb- wharton jelly
- Status last verified
- Jul 2013
- First submitted
- 26 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Matrix Remodeling of the Umbilical Cord and Placenta in Preeclampsia
- ClinicalTrials.gov ID
- NCT01931891
- Acronym / sponsor ID
- ztb- wharton jelly
- Conditions
- Alterations of ECM in Umbilical Cord ECM in Preeclampisa, Alterations of ECM in Placenta in Preeclampisa
- Keywords
- preeclampsia, ADAMTS , wharton jelly, extracellüler matrix, placenta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Collaborators
- Turgut Ozal University
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- 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.
Preeclampsia affects 2% to 8% of all pregnancies and is a major cause of maternal morbidity an mortality worldwide.Althought the primary pathology leading to preeclampsia is remain not known, complex pathophysiologic pathways and mechanisms have been described.
New blood vessels evolve during angiogenesis and vasculogenesis, two physiological processes, that play a crucial role in embryogenesis and placentation. Structural alterations in the human umbilical cord, maternal spiral arteries can cause adverse fetal consequences.Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
Matrixmetalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various components of the extracellular matrix (ECM). A Disintegrin And Metalloproteinases (ADAMs) and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix Metalloproteinases (MMPs). Dysregulation of ADAMs and ADAMTS expression have been reported in different types of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation or asthma.
The role of ADAMTS in the pathomechanism of pre-eclampsia has not been studied until now. We therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from newborns of mothers with pre-eclampsia with those with normal pregnancy.
Detailed description
Preeclampsia is a multi-systemic disorder. Despite its seriousness, the aetyology remains unknown. Current theories include abnormal placentation, cardiovascular maladaptation to pregnancy, genetic and immune mechanisms, angiogenic factors and an enhanced systemic inflammatory response. Poor placental perfusion leading to wide spread maternal endothelial dysfunction is accepted as a major mechanism.
The trophoblastic invasion of maternal vessels results many changes in extracellular matrix, which gives rise to high uteroplacental vessel distensibility to accommodate the increased blood flow. So, İn normal pregnancy, there is a wide spread vasodilatation, with increased arterial compliance and reduced peripheral vascular resistance.In preeclampsia, however, trophoblastic invasion is reduced, leading to incomplete modification of maternal spiral arteries and therefore to decreases in placental perfusion.
Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord and placenta. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
Matrix metalloproteinases (MMPs) are a family of proteolytic enzymes that degrade various components of the extracellularmatrix (ECM). These enzymes play an essential role in physiological states such as tissue remodeling, morphogenesis and wound healing anda lso in pathological processes such as tumor cell invasion and metastasis.
A Disintegrin And Metalloproteinases (ADAMs) and ADAMs with Thrombospondin motifs (ADAMTS) are proteinases closely related to Matrix Metalloproteinases (MMPs). Dysregulation of ADAMsexpression has beenreported in differenttypes of pathologies such as cancer, osteoarthritis, neurodegenerative inflammation or asthma.
Some authors suggestted that ADAM-8, -9, -10, -12, -15, -17, and ADAMTS-1 might play roles in uterus remodeling during the periimplantation period and ADAMTS-12, independent of its proteolytic activity, plays a critical role in human trophoblastic cell invasion in vitro.
Human umbilical cord is an extra-embryonic structure linking the mother and fetus during pregnancy In the umbilical cord two arteries and one vein are surrounded by a collagen-rich, myxomatous substance, called Wharton's jelly (WJ) that protect the umbilical vessels against extension, bending, twisting and compression.
The extracellular matrix (ECM) of WJ is very copious and contains significant amounts of hyaluronic acid and some sulphated glycosaminoglycans (GAGs). İts interesting that Wharton's jelly contain a low number of cells but large amounts of collagen and GAGs. Wharton's jelly plays also an important role as a storage for some compounds, such as growth factor. Previous studies demonstrated that both human umbilical cord serum and tissues contain large amounts of IGF-I and IGF-binding proteins (BPs), mainly BP-1 and BP-3.
Structural alterations in the human umbilical cord can cause adverse fetal consequences. ECM dynamics can result from changes of ECM composition, for example, because of altered synthesis or degradation of one or more ECM components, or in architecture because of altered organization. Pre-eclampsia is accompanied by an extensive remodelling of the ECM of the umbilical cord.
İt found that significant increase in collagen content in the umbilical cord arteries and vein and premature replacement of hyaluronic acid by sulfated GAGs both in the UCAs and in Wharton's jelly in preeclampsia. Pre-eclamptic Wharton's jelly contains higher amounts of glycosaminoglycans in comparison to control tissue.
The role of ADAMTS in the pathology of pre-eclampsia has not been studied until now. We therefore decided to compare the ADAMTS composition of the umbilical cord and placenta from newborns of mothers with pre-eclampsia with those with normal pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prreclampsia | – | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- preeclamptic women
Key inclusion criteria (1 listed)
- Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)
Key exclusion criteria (2 listed)
- known chronic disease multipl pregnancies
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severe preclampsia
Time frame: 34 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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.
ayse kirbas, md principal investigator
zekai tahir burak hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alterations of ECM in Umbilical Cord ECM in Preeclampisa and Alterations of ECM in Placenta in Preeclampisa, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ayse kirbas, md (533-646-9213, ayseozdemirkirbas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe preclampsia (time frame: 34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2013.