Cardiovascular Changes in Infants of Preeclampsia Mother
Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preeclampsia is diagnosed according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria: BP > 140/90 on two occasions in previous normotensive mother after 20 weeks of gestation and one of the following; proteinuria in urine > 0.3 gram/kg/day or acute kidney or liver dysfunction or signs of uterine dysfunction. The onset of preeclampsia can be early before 34 weeks of pregnancy (Early-onset preeclampsia) or late after 34 weeks of pregnancy (Late-onset preeclampsia). Early-onset preeclampsia, especially between 28-32 weeks gestation, is characterized by a high prevalence of microvascular changes in the placenta that makes mothers and their infants are more liable to complication. The pathogenesis of preeclampsia is unclear.
Preeclampsia affects hematopoiesis and the fetal myeloid lineage leading to thrombocytopenia, neutropenia, decrease phagocytic function, decrease T regulatory cells, and an increase in cytotoxic natural killer cells in neonates. Innate and adaptive immunity are regulated by myeloid cells and the immune changes in infants of preeclampsia mothers could lead to increased incidence of neonatal sepsis and the development of chronic inflammatory conditions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Infants born from Pregnant women with preeclampsia, their mother willing to give consent.
Exclusion Criteria:
- 1-Infant with a major heart problem.
- Infants with major congenital and genetic anomalies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: study group
new-born infants born from preeclampsia mother
|
performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
|
|
Other: control group
new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race
|
performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac changes
Time Frame: within 72 hours after birth
|
cardiac output will be presented by ml/minute
|
within 72 hours after birth
|
|
Cardiac function changes
Time Frame: within 72 hours after birth
|
Fractional shortening and ejection fraction will be presented by percentage
|
within 72 hours after birth
|
|
Vascular changes in superior mesenteric and anterior cerebral arteries
Time Frame: 72 hours after birth
|
Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second |
72 hours after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feeding problem
Time Frame: 3 months after birth
|
rate of necrotizing enterocolitis and feeding intolerance
|
3 months after birth
|
|
oval all outcomes
Time Frame: 3 months
|
Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
|
3 months
|
|
immunological changes
Time Frame: cord blood at birth
|
interleukins level
|
cord blood at birth
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ananth CV, Keyes KM, Wapner RJ. Pre-eclampsia rates in the United States, 1980-2010: age-period-cohort analysis. BMJ. 2013 Nov 7;347:f6564. doi: 10.1136/bmj.f6564.
- Hansen AR, Barnes CM, Folkman J, McElrath TF. Maternal preeclampsia predicts the development of bronchopulmonary dysplasia. J Pediatr. 2010 Apr;156(4):532-6. doi: 10.1016/j.jpeds.2009.10.018. Epub 2009 Dec 14.
- Marins LR, Anizelli LB, Romanowski MD, Sarquis AL. How does preeclampsia affect neonates? Highlights in the disease's immunity. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1205-1212. doi: 10.1080/14767058.2017.1401996. Epub 2017 Nov 20.
- Bujold E, Chaiworapongsa T, Romero R, Gervasi MT, Espinoza J, Goncalves LF, Berman S, Yoon BH, Kim YM. Neonates born to pre-eclamptic mothers have a higher percentage of natural killer cells (CD3-/CD56+16+) in umbilical cord blood than those without pre-eclampsia. J Matern Fetal Neonatal Med. 2003 Nov;14(5):305-12. doi: 10.1080/jmf.14.5.305.312.
- Ness RB, Sibai BM. Shared and disparate components of the pathophysiologies of fetal growth restriction and preeclampsia. Am J Obstet Gynecol. 2006 Jul;195(1):40-9. doi: 10.1016/j.ajog.2005.07.049. Epub 2006 Apr 21.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cardiovascularpreeclampsia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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