The Expression of Aquaporin 3, 8 and 9 in Placenta in Normal and Preeclamptic Pregnancies: Perinatal and Neonatal Outcomes.

Preeclampsia Clinical Trial

Official title:

The Expression of Aquaporin 3, 8 and 9 in Placenta, Umbilical Cord and Fetal Membranes in Normal Pregnancies and Pregnancies Complicated by Preeclampsia: Perinatal and Neonatal Outcomes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02045316
• Other study ID #: RA-221281
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: January 22, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: Trakya University
• Contact: Rakhshanda Aslanova, MD
• Phone: +902842357641
• Email: rahshanda[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

The investigators are carrying out a study of 210 pregnant women , from whom 105 will have pregnancy complicated with preeclampsia and 105 with normal pregnancy.

The investigators aim is to investigate the role of the placenta, umbilical cord and amniotic membrane aquaporin expression in etiopathogenesis of preeclampsia. The investigators will compare aquaporin levels in preeclamptic and normal placentas, umbilical cords and amniotic membranes , and investigate relation between aquaporin levels and perinatal ( maternal blood pressure, proteinuria, maternal-fetal doppler ultrasound, amniotic fluid index, fetal intrauterine growth) and neonatal ( Apgar score, biometry, complications) finding.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

Inclusion Criteria:

• Preeclamptic pregnants

• Normal non-complicated pregnants

Exclusion Criteria:

-Pregnants with another obstetric complications

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Rakhshanda Aslanova

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Epub 2006 Feb 9. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunohistochemistry	Compare aquaporin levels in normal and preeclamptic placentas	up to 2 week	No
Secondary	Statistical analysis	Correlate aquaporin expression with perinatal and neonatal outcomes	up to 2 week	No