Thrombocytopenia Clinical Trial
Official title:
Clinical Research: Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
Verified date | June 2016 |
Source | Guangdong Women and Children Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objective:The purpose of this study was to explore the effect and mechanism of maternal
chorioamnionitis on placental microvasculature and platelet activation among preterm infants
by activating Wnt-Flt1 signal pathway .
Methods:With clinical randomized controlled trial (RCT), the cases were matched with 1:1
according to gestational age and divided into 2 groups according to the placental pathology
result: chorioamnionitis group and control group. (1) To observe the platelet parameter,
birth weight, thrombrocytopenia and hemorrhage complication, such as intracranial hemorrhage,
retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage. (2) To observe the
miscrovascular density (MVD) in placenta, platelet activating factor (CD62p,CD63) and
thrombopotetin (TPO) in preterrn infants.The placental MVD was assessed by
immunohistochemical method. The platelet activating factors were detected by flow cytometry.
TPO was detected by ELISA. (3) To observe Wnt5a, Flt1 and VEGF in placenta and fetal
circulation.The measurement data were analyzed by pair t test and conditional logistic
regression. Pearson correlation analysis was used for relationship.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. gestational age<37weeks 2. admitted to the NICU at Guangdong Women and Children Hospital, with a date of birth from June 2016 to December 2016 3. whose mothers were diagnosed chorioamnionitis by placental histopathology Exclusion Criteria: 1. born to mother with no any other maternal complications 2. no congenital abnormalities and neonatal asphyxia; 3. died or discharged within 72 hours. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Guangdong Women and Children Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Placental Microvascular Density(%) | Placental Microvascular Density (by placental histopathology) | 24 hours | |
Secondary | Incidence Hemorrhage Disease (%) | intraventricular hemorrhage (IVH), retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage | through study completion, an average of half year | |
Secondary | Wnt5a in Placenta(IOD) | by placental histopathology | 24 hours | |
Secondary | mean platelet volume(MPV) | MPV (Fl) | 24 hours | |
Secondary | platelet distribution width(PDW) | PDW (%) | 24 hours | |
Secondary | Platelet counts (PLT) | PLT (10^9/L) | 24 hours | |
Secondary | Thrombopoietin (cord blood) | TPO(ng/ml) | 24 hours | |
Secondary | Platelets Activation Factors in cord blood | CD62p(%) | 24 hours | |
Secondary | Flt1 in Placenta(IOD) | by placental histopathology | 24 hours | |
Secondary | VEGF in Placenta(IOD) | by placental histopathology | 24 hours | |
Secondary | Wnt5 in infants (ng/ml) | test them by Elisa from cord blood | 24 hours | |
Secondary | Flt1 in infants (ng/ml) | test them by Elisa from cord blood | 24 hours | |
Secondary | VEGF in infants (ng/ml) | test them by Elisa from cord blood | 24 hours |
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