Cardiovascular Changes in Infants of Preeclampsia Mother
Primary Purpose
Pre-Eclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiovascular and immunological changes
Sponsored by
About this trial
This is an interventional basic science trial for Pre-Eclampsia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
study group
control group
Arm Description
new-born infants born from preeclampsia mother
new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race
Outcomes
Primary Outcome Measures
Cardiac changes
cardiac output will be presented by ml/minute
Cardiac function changes
Fractional shortening and ejection fraction will be presented by percentage
Vascular changes in superior mesenteric and anterior cerebral arteries
Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity.
All will be measured in meter/second
Secondary Outcome Measures
Feeding problem
rate of necrotizing enterocolitis and feeding intolerance
oval all outcomes
Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
immunological changes
interleukins level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04699825
Brief Title
Cardiovascular Changes in Infants of Preeclampsia Mother
Official Title
Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preeclampsia (hypertension during pregnancy) is a common problem affecting 2-8% of pregnancies worldwide and is typically diagnosed by increased blood pressure and proteinuria. The rate of preeclampsia has increased since the 1980s with higher rates at extreme maternal ages as well as during the first pregnancy. Pre-eclampsia is a serious hypertensive disorder of pregnancy affecting outcomes for both mother and infants. These infants not only have increased risk of neonatal complications including preterm birth, intrauterine growth restriction, abnormal Doppler parameters, feed intolerance, intestinal problem, poor growth, and long term lung condition but also have increased risk of cerebral palsy, abnormal neurodevelopmental outcomes, cardiovascular disease, stroke, and mental disorders during childhood and adulthood.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Active Comparator
Arm Description
new-born infants born from preeclampsia mother
Arm Title
control group
Arm Type
Other
Arm Description
new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race
Intervention Type
Other
Intervention Name(s)
Cardiovascular and immunological changes
Intervention Description
performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
Primary Outcome Measure Information:
Title
Cardiac changes
Description
cardiac output will be presented by ml/minute
Time Frame
within 72 hours after birth
Title
Cardiac function changes
Description
Fractional shortening and ejection fraction will be presented by percentage
Time Frame
within 72 hours after birth
Title
Vascular changes in superior mesenteric and anterior cerebral arteries
Description
Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity.
All will be measured in meter/second
Time Frame
72 hours after birth
Secondary Outcome Measure Information:
Title
Feeding problem
Description
rate of necrotizing enterocolitis and feeding intolerance
Time Frame
3 months after birth
Title
oval all outcomes
Description
Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
Time Frame
3 months
Title
immunological changes
Description
interleukins level
Time Frame
cord blood at birth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S Ali
Phone
7309405405
Email
ahmedsalehali@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No, we will take consent from participant in this study only.
Citations:
PubMed Identifier
24201165
Citation
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.
Results Reference
background
PubMed Identifier
20004912
Citation
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.
Results Reference
background
PubMed Identifier
29113524
Citation
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.
Results Reference
background
PubMed Identifier
14986803
Citation
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.
Results Reference
background
PubMed Identifier
16813742
Citation
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.
Results Reference
background
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Cardiovascular Changes in Infants of Preeclampsia Mother
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