- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368821
From Cytotrophoblast to Syncytiotrophoblast
From Cytotrophoblast to Syncytiotrophoblast - Telomere Length, Aggregate Formation and Senescence in Placenta From Complicated Pregnancies Compare to Placenta From Normal Pregnancies.
Study Overview
Status
Conditions
Detailed Description
Protocol summary No. 2 for research 0202-14 of date: 22/11/2014. Rationale for the research A deeper understanding of the syncytiotrophoblast development processes and its properties may allow a better understanding of the placenta pathological process for the development of treatment models for the relevant pregnancy complications.
The aim of this study is to compare telomere length, aggregate formation, and senescence markers in the syncytiotrophoblast of placentas from complicated pregnancy with placentas from normal pregnancy.
Telomere lenght and aggregate formation will be assessed by the fluorescent intensity of telomere FISH.
Senescence will be assessed by immunohistochemistry for the markers - SAHF, cyclin dependent kinase inhibitors p16/p21, HLAX, ERVWE1, SA-B-gal.
The study groups
- A retrospective arm - paraffin blocks which were collected over the years from placentas from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) will be compared to blocks of placentas from normal pregnancies.
- The prospective arm - placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete) . Will be compared to placentas of normal pregnancies.
- A laboratory model based on human placenta cell cultures
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- placentas from normal and complicated pregnancy
Exclusion Criteria:
- women consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
Cohorts and Interventions
Group / Cohort |
---|
normal pregnancy
placental from normal pregnancy
|
complacted pregnancy
placental from complicated pregnancy ( intrauterine growth restriction, preeclampsia , placenta accrete
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of telomere and senescence markers amount in the placentas.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0202-14-MMC
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