Clinical trial NCT03636698: Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
Official title: Clinical Research: Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chorioamnionitis
Placenta Diseases
Thrombocytopenia
Preterm Infant
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chorioamnionitis contributes to the high morbidity and mortality in preterm infants, thrombocytopenia is one of the acute morbidity

Brief summary: 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.

Detailed description: The exclusive criteria included :(1) born to mother with no any other maternal complications; (2) no congenital abnormalities and neonatal asphyxia; (3) died or discharged within 72 hours.

Eligibility criteria: 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.

Primary outcomes:
measure: Placental Microvascular Density(%)
timeFrame: 24 hours
Secondary outcomes:
measure: Incidence Hemorrhage Disease (%)
timeFrame: through study completion, an average of half year
measure: Wnt5a in Placenta(IOD)
timeFrame: 24 hours
measure: mean platelet volume(MPV)
timeFrame: 24 hours
measure: platelet distribution width(PDW)
timeFrame: 24 hours
measure: Platelet counts (PLT)
timeFrame: 24 hours
measure: Thrombopoietin (cord blood)
timeFrame: 24 hours
measure: Platelets Activation Factors in cord blood
timeFrame: 24 hours
measure: Flt1 in Placenta(IOD)
timeFrame: 24 hours
measure: VEGF in Placenta(IOD)
timeFrame: 24 hours
measure: Wnt5 in infants (ng/ml)
timeFrame: 24 hours
measure: Flt1 in infants (ng/ml)
timeFrame: 24 hours
measure: VEGF in infants (ng/ml)
timeFrame: 24 hours
Other outcomes:
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