PreeclampsiaNCT02045316
The Expression of Aquaporin 3, 8 and 9 in Placenta in Normal and Preeclamptic Pregnancies: Perinatal and Neonatal Outcomes.
An observational study of Preeclampsia, run by Rakhshanda Aslanova at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to 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 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 105 pregnant women with preeclampsia and 105 women with normal pregnancy, who applied to Trakya University Faculty of Medicine's.
Who may be able to join
- Preeclamptic pregnants
- Normal non-complicated pregnants
Who cannot join
- -Pregnants with another obstetric complications
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the detailed 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.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Aquaporins, 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 |
|---|---|---|
| Preeclamptic pregnants | pregnants with preeclampsia | |
| Normal pregnants | pregnants without obstetric complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunohistochemistry
Compare aquaporin levels in normal and preeclamptic placentas
Measured: up to 2 week
Secondary outcomes (1)
Statistical analysis
Correlate aquaporin expression with perinatal and neonatal outcomes
Measured: up to 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rakhshanda Aslanova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rakhshanda Aslanova, Trakya University
- Investigators
- Cenk Sayin, Professor, Study chair, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045316
- Sponsor's protocol ID
- RA-221281
- Status last verified
- Jan 2014
- First submitted
- 18 Nov 2013
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21208655Damiano 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.
PubMed 16480766Leung 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.
PubMed 11349196Marino 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.
PubMed 20220109Castro-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.
PubMed 19481256Damiano 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.
PubMed 11597198
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02045316
- Acronym / sponsor ID
- RA-221281
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Aquaporins, Placenta
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Rakhshanda AslanovaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 24 Jan 2014 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preeclamptic pregnants | – | –pregnants with preeclampsia |
| Normal pregnants | – | –pregnants without obstetric complications |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 105 pregnant women with preeclampsia and 105 women with normal pregnancy, who applied to Trakya University Faculty of Medicine's.
Key inclusion criteria (2 listed)
- Preeclamptic pregnants
- Normal non-complicated pregnants
Key exclusion criteria (1 listed)
- -Pregnants with another obstetric complications
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
immunohistochemistry
Time frame: up to 2 week
Compare aquaporin levels in normal and preeclamptic placentas
1 secondary outcome
Statistical analysis
Time frame: up to 2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
- Background: PubMed 21208655Damiano 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.
- Background: PubMed 16480766Damiano 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.
- Background: PubMed 11349196Leung 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.
- Background: PubMed 20220109Marino 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.
- Background: PubMed 19481256Castro-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.
- Background: PubMed 11597198Damiano 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.
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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.
Cenk Sayin, Professor study chair
Trakya University
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 Preeclampsia, run by Rakhshanda Aslanova 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 2 inclusion and 1 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 24 Jan 2014. 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 Rakhshanda Aslanova, MD (+902842357641 ext. 4300, rahshanda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunohistochemistry (time frame: up to 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045316, which also lists 6 linked publications.
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 24 Jan 2014.