NCT02045316

Brief Summary

The etiologic agent responsible for the development of preeclampsia remains unknown. Aquaporins, members of integral membrane proteins, are responsible of water molecules movements through the plasma membrane channels, energy metabolism and associated with changes in cellular volume during apoptosis. İn such placental pathology as preeclampsia, characterized with superficial implantation and increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of aquaporins important role in energy homeostasis and apoptosis maybe suggested.

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
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 24, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

November 18, 2013

Last Update Submit

January 22, 2014

Conditions

Preeclampsia

Keywords

PreeclampsiaAquaporinsPlacenta

Outcome Measures

Primary Outcomes (1)

  • immunohistochemistry

    Compare aquaporin levels in normal and preeclamptic placentas

    up to 2 week

Secondary Outcomes (1)

  • Statistical analysis

    up to 2 week

Study Arms (2)

Preeclamptic pregnants

pregnants with preeclampsia

Normal pregnants

pregnants without obstetric complications

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

105 pregnant women with preeclampsia and 105 women with normal pregnancy, who applied to Trakya University Faculty of Medicine's.

You may qualify if:

  • Preeclamptic pregnants
  • Normal non-complicated pregnants

You may not qualify if:

  • Pregnants with another obstetric complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22000, Turkey (Türkiye)

Location

Related Publications (6)

  • Damiano AE. Review: Water channel proteins in the human placenta and fetal membranes. Placenta. 2011 Mar;32 Suppl 2:S207-11. doi: 10.1016/j.placenta.2010.12.012. Epub 2011 Jan 5.

    PMID: 21208655BACKGROUND

  • Damiano AE, Zotta E, Ibarra C. Functional and molecular expression of AQP9 channel and UT-A transporter in normal and preeclamptic human placentas. Placenta. 2006 Nov-Dec;27(11-12):1073-81. doi: 10.1016/j.placenta.2005.11.014. Epub 2006 Feb 9.

    PMID: 16480766BACKGROUND

  • Leung DN, Smith SC, To KF, Sahota DS, Baker PN. Increased placental apoptosis in pregnancies complicated by preeclampsia. Am J Obstet Gynecol. 2001 May;184(6):1249-50. doi: 10.1067/mob.2001.112906.

    PMID: 11349196BACKGROUND

  • Marino GI, Castro-Parodi M, Dietrich V, Damiano AE. High levels of human chorionic gonadotropin (hCG) correlate with increased aquaporin-9 (AQP9) expression in explants from human preeclamptic placenta. Reprod Sci. 2010 May;17(5):444-53. doi: 10.1177/1933719110361385. Epub 2010 Mar 10.

    PMID: 20220109BACKGROUND

  • Castro-Parodi M, Levi L, Dietrich V, Zotta E, Damiano AE. CFTR may modulate AQP9 functionality in preeclamptic placentas. Placenta. 2009 Jul;30(7):642-8. doi: 10.1016/j.placenta.2009.04.012. Epub 2009 May 28.

    PMID: 19481256BACKGROUND

  • Damiano A, Zotta E, Goldstein J, Reisin I, Ibarra C. Water channel proteins AQP3 and AQP9 are present in syncytiotrophoblast of human term placenta. Placenta. 2001 Sep-Oct;22(8-9):776-81. doi: 10.1053/plac.2001.0717.

    PMID: 11597198BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cenk Sayin, Professor

    Trakya University

    STUDY CHAIR

Central Study Contacts

Rakhshanda Aslanova, MD

CONTACT

+902842357641rahshanda@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2013

First Posted

January 24, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

January 24, 2014

Record last verified: 2014-01

Locations

TU(1)