ChorioamnionitisNCT03636698
Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
An observational study of Chorioamnionitis and Placenta Diseases, run by Guangdong Women and Children Hospital.
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 . Read more about this study
- Who is it for?
- Ages 1 hour and olderHealthy volunteers can take part
- Conditions the study is for
- Chorioamnionitis, Placenta Diseases, Thrombocytopenia
- What is being tested?
- chorioamnionitis
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chorioamnionitis contributes to the high morbidity and mortality in preterm infants, thrombocytopenia is one of the acute morbidity
Who may be able to join
- 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
Who cannot join
- born to mother with no any other maternal complications
- no congenital abnormalities and neonatal asphyxia;
- died or discharged within 72 hours.
About this study
Official title: 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.
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.
- Conditions
- Chorioamnionitis, Placenta Diseases, Thrombocytopenia, Preterm Infant
- Being tested
- chorioamnionitis
- Medical subject headings
- Chorioamnionitis, Placenta Diseases, Thrombocytopenia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chorioamnionitisOther
It is a observation research. We didn't intervene anything. The chorioamnionitis groups included the infants whose mothers were diagnosed chorioamnionitis by placental histopathology.
| Study group | Role | What they receive |
|---|---|---|
| Chorioamnionitis Group | preterm infants were born to mothers with chorioamnionitis Receives: Other: chorioamnionitis | |
| Control Group | preterm infants were born to mothers without chorioamnionitis Receives: Other: chorioamnionitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental Microvascular Density(%)
Placental Microvascular Density (by placental histopathology)
Measured: 24 hours
Secondary outcomes (12)
Incidence Hemorrhage Disease (%)
intraventricular hemorrhage (IVH), retinal hemorrhage, pulmonary hemorrhage and gastrointestinal hemorrhage
Measured: through study completion, an average of half year
Wnt5a in Placenta(IOD)
by placental histopathology
Measured: 24 hours
mean platelet volume(MPV)
MPV (Fl)
Measured: 24 hours
platelet distribution width(PDW)
PDW (%)
Measured: 24 hours
Platelet counts (PLT)
PLT (10^9/L)
Measured: 24 hours
Thrombopoietin (cord blood)
TPO(ng/ml)
Measured: 24 hours
Platelets Activation Factors in cord blood
CD62p(%)
Measured: 24 hours
Flt1 in Placenta(IOD)
by placental histopathology
Measured: 24 hours
VEGF in Placenta(IOD)
by placental histopathology
Measured: 24 hours
Wnt5 in infants (ng/ml)
test them by Elisa from cord blood
Measured: 24 hours
Flt1 in infants (ng/ml)
test them by Elisa from cord blood
Measured: 24 hours
VEGF in infants (ng/ml)
test them by Elisa from cord blood
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jun 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yangjie, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636698
- Sponsor's protocol ID
- Guangdong W&C Hospital
- Status last verified
- Jun 2016
- First submitted
- 1 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research: Effect of Chorioamnionitis on Platelet Activation and Placental Vessel Among Preterm Infants by Wnt-Flt1 Signal Pathway
- ClinicalTrials.gov ID
- NCT03636698
- Acronym / sponsor ID
- Guangdong W&C Hospital
- Conditions
- Chorioamnionitis, Placenta Diseases, Thrombocytopenia, Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangdong Women and Children HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chorioamnionitis Group | – | Other: chorioamnionitispreterm infants were born to mothers with chorioamnionitis |
| Control Group | – | Other: chorioamnionitispreterm infants were born to mothers without chorioamnionitis |
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chorioamnionitis contributes to the high morbidity and mortality in preterm infants, thrombocytopenia is one of the acute morbidity
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- born to mother with no any other maternal complications
- no congenital abnormalities and neonatal asphyxia;
- died or discharged within 72 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chorioamnionitisIt is a observation research. We didn't intervene anything. The chorioamnionitis groups included the infants whose mothers were diagnosed chorioamnionitis by placental histopathology. | Other | Chorioamnionitis Group, Control Group |
Primary outcome
Placental Microvascular Density(%)
Time frame: 24 hours
Placental Microvascular Density (by placental histopathology)
12 secondary outcomes
Incidence Hemorrhage Disease (%)
Time frame: through study completion, an average of half year
Wnt5a in Placenta(IOD)
Time frame: 24 hours
mean platelet volume(MPV)
Time frame: 24 hours
platelet distribution width(PDW)
Time frame: 24 hours
Platelet counts (PLT)
Time frame: 24 hours
Thrombopoietin (cord blood)
Time frame: 24 hours
Platelets Activation Factors in cord blood
Time frame: 24 hours
Flt1 in Placenta(IOD)
Time frame: 24 hours
VEGF in Placenta(IOD)
Time frame: 24 hours
Wnt5 in infants (ng/ml)
Time frame: 24 hours
Flt1 in infants (ng/ml)
Time frame: 24 hours
VEGF in infants (ng/ml)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chorioamnionitis and Placenta Diseases, run by Guangdong Women and Children Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental Microvascular Density(%) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.