NCT01931891

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 30, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

August 26, 2013

Last Update Submit

August 28, 2013

Conditions

Keywords

preeclampsia, ADAMTS , wharton jelly, extracellüler matrix, placenta

Outcome Measures

Primary Outcomes (1)

  • severe preclampsia

    34 weeks

Study Arms (1)

prreclampsia

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

preeclamptic women

You may qualify if:

  • Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

You may not qualify if:

  • known chronic disease multipl pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Maternity Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

umbilical cord placenta

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • ayse kirbas, md

    zekai tahir burak hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zekai Tahir Burak Maternity and Teaching Hospital

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2014

Study Completion

July 1, 2014

Last Updated

August 30, 2013

Record last verified: 2013-07

Locations