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NCT Number: NCT03636698

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.

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Key information

Conditions

Chorioamnionitis Blood Platelet Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytopenia Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Membranes, Premature Rupture Hematologic Diseases Hemic and Lymphatic Diseases Obstetric Labor Complications Obstetric Labor, Premature Placenta Diseases Pregnancy Complications Premature Birth Preterm Infant Thrombocytopenia Urogenital Diseases

Age range

1 hour and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gestational age<37weeks
  • admitted to the NICU at Guangdong Women and Children Hospital, with a date of birth from June 2016 to December 2016
  • whose mothers were diagnosed chorioamnionitis by placental histopathology

Exclusion criteria

  • born to mother with no any other maternal complications
  • no congenital abnormalities and neonatal asphyxia;
  • died or discharged within 72 hours.

Treatment and study plan

chorioamnionitis

Other

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

Primary outcomes

  1. Placental Microvascular Density(%)

    Time frame: 24 hours

    Placental Microvascular Density (by placental histopathology)

Secondary outcomes

  1. Incidence Hemorrhage Disease (%)

    Time frame: through study completion, an average of half year

    intraventricular hemorrhage (IVH), retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage

  2. Wnt5a in Placenta(IOD)

    Time frame: 24 hours

    by placental histopathology

  3. mean platelet volume(MPV)

    Time frame: 24 hours

    MPV (Fl)

  4. platelet distribution width(PDW)

    Time frame: 24 hours

    PDW (%)

  5. Platelet counts (PLT)

    Time frame: 24 hours

    PLT (10^9/L)

  6. Thrombopoietin (cord blood)

    Time frame: 24 hours

    TPO(ng/ml)

  7. Platelets Activation Factors in cord blood

    Time frame: 24 hours

    CD62p(%)

  8. Flt1 in Placenta(IOD)

    Time frame: 24 hours

    by placental histopathology

  9. VEGF in Placenta(IOD)

    Time frame: 24 hours

    by placental histopathology

  10. Wnt5 in infants (ng/ml)

    Time frame: 24 hours

    test them by Elisa from cord blood

  11. Flt1 in infants (ng/ml)

    Time frame: 24 hours

    test them by Elisa from cord blood

  12. VEGF in infants (ng/ml)

    Time frame: 24 hours

    test them by Elisa from cord blood

Sponsors and collaborators

Lead sponsor

Guangdong Women and Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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