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CompletedNCT03636698Updated Aug 17, 2018

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

An observational study in Chorioamnionitis, Placenta Diseases and Thrombocytopenia, sponsored by Guangdong Women and Children Hospital. Completed. Open to participants aged 1 Hour and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Guangdong Women and Children Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
64
Ages
1 Hour and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chorioamnionitis
  • Placenta Diseases
  • Thrombocytopenia
  • Preterm Infant
03

In context

Chorioamnionitis

39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.

This study's enrollment of 64 is below the median of 125 across 14 observational studies indexed under Chorioamnionitis.

Browse Chorioamnionitis studies →

Lead sponsor

Guangdong Women and Children Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Chorioamnionitis Group

    preterm infants were born to mothers with chorioamnionitis

    Other: chorioamnionitis

  • Control Group

    preterm infants were born to mothers without chorioamnionitis

    Other: chorioamnionitis

Interventions

  • Otherchorioamnionitis

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

06

What researchers measure

Primary outcomes

  1. Placental Microvascular Density(%)

    Placental Microvascular Density (by placental histopathology)

    Time frame: 24 hours

Secondary outcomes

  1. Incidence Hemorrhage Disease (%)

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

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

  2. Wnt5a in Placenta(IOD)

    by placental histopathology

    Time frame: 24 hours

  3. mean platelet volume(MPV)

    MPV (Fl)

    Time frame: 24 hours

  4. platelet distribution width(PDW)

    PDW (%)

    Time frame: 24 hours

  5. Platelet counts (PLT)

    PLT (10\^9/L)

    Time frame: 24 hours

  6. Thrombopoietin (cord blood)

    TPO(ng/ml)

    Time frame: 24 hours

  7. Platelets Activation Factors in cord blood

    CD62p(%)

    Time frame: 24 hours

  8. Flt1 in Placenta(IOD)

    by placental histopathology

    Time frame: 24 hours

  9. VEGF in Placenta(IOD)

    by placental histopathology

    Time frame: 24 hours

  10. Wnt5 in infants (ng/ml)

    test them by Elisa from cord blood

    Time frame: 24 hours

  11. Flt1 in infants (ng/ml)

    test them by Elisa from cord blood

    Time frame: 24 hours

  12. VEGF in infants (ng/ml)

    test them by Elisa from cord blood

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03636698
Lead sponsor
Guangdong Women and Children Hospital
Responsible party
yangjie (Chief of Neontology Dept, Guangdong Women and Children Hospital) — Principal investigator
First posted
Aug 17, 2018
Start date
Jun 1, 2016
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Aug 17, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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