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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03636698
Other study ID # Guangdong W&C Hospital
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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