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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • Zekai Tahir Burak Maternity Hospital

    Ankara

    nuri danisman, md, 306-5000

    ayse kirbas, md

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT01931891
Study groupRoleWhat they receive
prreclampsiaNot described

What is being measured

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

  1. 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.

  1. First posted29 Aug 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionFeb 2014 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

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)
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

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.

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