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

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

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.

Study Overview

• Status: Completed
• Conditions: Chorioamnionitis; Placenta Diseases; Thrombocytopenia; Preterm Infant
• Intervention / Treatment: Other: chorioamnionitis

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 Type: Observational
• Enrollment (Actual): 64

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chorioamnionitis contributes to the high morbidity and mortality in preterm infants, thrombocytopenia is one of the acute morbidity

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chorioamnionitis Group; preterm infants were born to mothers with chorioamnionitis	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.
Control Group; preterm infants were born to mothers without chorioamnionitis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental Microvascular Density(%)	Placental Microvascular Density (by placental histopathology)	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Women and Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Fetal Diseases; Pregnancy Complications; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Blood Platelet Disorders; Obstetric Labor, Premature; Chorioamnionitis; Premature Birth; Thrombocytopenia; Placenta Diseases
• Other Study ID Numbers: Guangdong W&C Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No