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

Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636698
• Other study ID #: Guangdong W&C Hospital
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2016
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chorioamnionitis
• Placenta Diseases
• Premature Birth
• Preterm Infant
• Thrombocytopenia

Intervention

Other:
• chorioamnionitis
It is a observation research. We didn't intervene anything. The chorioamnionitis groups included the infants whose mothers were diagnosed chorioamnionitis by placental histopathology.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Outcome

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