Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway

Completed

• Conditions: Thrombocytopenia; Chorioamnionitis; Placenta Diseases; Preterm Infant
• Interventions: Other: chorioamnionitis

• Registration Number: NCT03636698
• Lead Sponsor: Guangdong Women and Children Hospital

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	chorioamnionitis	preterm infants were born to mothers without chorioamnionitis
Chorioamnionitis Group	chorioamnionitis	preterm infants were born to mothers with chorioamnionitis

Primary Outcome Measures

Name	Time	Method
Placental Microvascular Density(%)	24 hours	Placental Microvascular Density (by placental histopathology)

Secondary Outcome Measures

Name	Time	Method
Wnt5 in infants (ng/ml)	24 hours	test them by Elisa from cord blood
Flt1 in infants (ng/ml)	24 hours	test them by Elisa from cord blood
Platelets Activation Factors in cord blood	24 hours	CD62p(%)
Thrombopoietin (cord blood)	24 hours	TPO(ng/ml)
mean platelet volume(MPV)	24 hours	MPV (Fl)
Platelet counts (PLT)	24 hours	PLT (10\^9/L)
Incidence Hemorrhage Disease (%)	through study completion, an average of half year	intraventricular hemorrhage (IVH), retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage
Flt1 in Placenta(IOD)	24 hours	by placental histopathology
VEGF in infants (ng/ml)	24 hours	test them by Elisa from cord blood
Wnt5a in Placenta(IOD)	24 hours	by placental histopathology
platelet distribution width(PDW)	24 hours	PDW (%)
VEGF in Placenta(IOD)	24 hours	by placental histopathology