Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn (ANGIODYS)
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| First Received Date ICMJE | July 20, 2012 | ||||||||
| Last Updated Date | July 20, 2012 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Levels of sFlt1 (tyrosine kinase 1) at birth and the risk of bronchopulmonary dysplasia [ Time Frame: at 36 weeks of gestational age ] [ Designated as safety issue: No ] The main objective of this population-based study, ie in 24 intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD at 36 weeks of gestational age. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Levels of angiogenic and antiangiogenic factors at birth and the complications of preterm birth [ Time Frame: at 36 weeks of gestational age ] [ Designated as safety issue: No ] The second objectives are to correlate the levels of angiogenic and antiangiogenic factors at birth, in maternal blood, cord blood and amniotic fluid, and the main complications of preterm birth, ie, necrotizing enterocolitis, intra-ventricular hemorrhage, periventricular leukomalacia or infection before 36 weeks of gestational age. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn | ||||||||
| Official Title ICMJE | Consequences of Circulating Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn | ||||||||
| Brief Summary | Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. The main objective of this population-based study, ie in intra uterine growth restricted preterm babies born before 30 weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD. |
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| Detailed Description | Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Preeclampsia is the main cause of intra-uterine growth restriction and could lead to a preterm delivery for fetal or maternal indication. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. Infants with maternal preeclampsia had higher cord blood sFlt-1 but lower PlGF and VEGF circulating levels. There was a significantly positive relationship between birth weight and cord blood sFlt-1 levels, witness of consequences of these antiangiogenic factors on fetuses. However, no study to date has shown a correlation between the level of angiogenic and antiangiogenic factors and the main complications of preterm birth. The main objective of this population-based study, ie in 24 intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD at 36 weeks of gestational age. The second objectives are to explore the link between the levels of angiogenic and antiangiogenic factors and the main complications of preterm birth, ie, necrotizing enterocolitis, intra-ventricular hemorrhage, periventricular leukomalacia or infection. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Biological samples
To measure the levels of sFlt1, angiogenic and antiangiogenic factors at birth in maternal blood, umbilical cord blood and in the amniotic fluid |
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| Study Group/Cohort (s) | Preterm babies
Intra uterine growth restricted preterm babies born before 30 weeks of gestational age from mother with preeclampsia
Intervention: Other: Biological samples |
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| Publications * | Not Provided | ||||||||
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* 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 24 | ||||||||
| Estimated Completion Date | January 2015 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01648855 | ||||||||
| Other Study ID Numbers ICMJE | NI 11030 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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