The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01883154 |
Recruitment Status : Unknown
Verified June 2013 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
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Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Meir Medical Center
Tracking Information | |||
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First Submitted Date | June 11, 2013 | ||
First Posted Date | June 21, 2013 | ||
Last Update Posted Date | June 21, 2013 | ||
Study Start Date | September 2013 | ||
Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
Rate of Copy Number Variations [ Time Frame: 10 yeras ] | ||
Original Primary Outcome Measures | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome | ||
Official Title | The Impact of Placental Factors on Fetal Intrauterine Growth and in Intrauterine Programming of the Metabolic Syndrome | ||
Brief Summary | Genetic and environmental factors are believed to play a major role in intrauterine growth and intrauterine programming. We intend to study genetic factors such as Telomere homeostasis, senescence, genomic instability and the presence of Genomic copy number variations in placental tissue from pregnancies complicated with Intrauterine growth restriction(IUGR), Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We also intend to assess these factors in cord blood and maternal blood. | ||
Detailed Description | Based on the previous data from our group as well as other laboratories, we postulate that there is a correlation between impaired telomere homeostasis, senescence genomic instability and intra-uterine programming in placentas and in fetuses exposed to suboptimal intrauterine conditions such as hypoxia or hyperglycemia. Improved understanding of the mechanisms that produce the genomic changes in IUGR placentas and their influence on later risks of developing the metabolic syndrome should provide basis for future research that might lead into improved outcome of IUGR fetuses. | ||
Study Type | Observational | ||
Study Design | Not Provided | ||
Target Follow-Up Duration | Not Provided | ||
Biospecimen | Retention: Samples With DNA Description: placental tissue ,fetal cord blood and maternal blood.
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Sampling Method | Non-Probability Sample | ||
Study Population | Samples from pregnancies complicated with IUGR, Gestational and pre gestational Diabetes, placentas from IVF pregnancies and from normal pregnancies. We intend to assess these factors in placental tissue, in cord blood and maternal blood. | ||
Condition | Normal Pregnancies | ||
Intervention | Not Provided | ||
Study Groups/Cohorts |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Unknown status | ||
Estimated Enrollment |
160 | ||
Original Estimated Enrollment | Same as current | ||
Estimated Study Completion Date | September 2023 | ||
Estimated Primary Completion Date | September 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Israel | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01883154 | ||
Other Study ID Numbers | loe135673ctil | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Current Responsible Party | Meir Medical Center | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor | Meir Medical Center | ||
Original Study Sponsor | Same as current | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | Meir Medical Center | ||
Verification Date | June 2013 |