NCT03636698

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

August 1, 2018

Last Update Submit

August 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Placental Microvascular Density(%)

    Placental Microvascular Density (by placental histopathology)

    24 hours

Secondary Outcomes (12)

  • Incidence Hemorrhage Disease (%)

    through study completion, an average of half year

  • Wnt5a in Placenta(IOD)

    24 hours

  • mean platelet volume(MPV)

    24 hours

  • platelet distribution width(PDW)

    24 hours

  • Platelet counts (PLT)

    24 hours

  • +7 more secondary outcomes

Study Arms (2)

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

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

Chorioamnionitis GroupControl Group

Eligibility Criteria

Age1 Hour+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

the placentas and cord blood after delivery

MeSH Terms

Conditions

ChorioamnionitisPlacenta DiseasesThrombocytopeniaPremature Birth

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaObstetric Labor, Premature

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Neontology Dept

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 17, 2018

Study Start

June 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

August 17, 2018

Record last verified: 2016-06