Cardiovascular Changes in Infants of Preeclampsia Mother

• ClinicalTrials.gov Identifier: NCT04699825
• Recruitment Status: Not yet recruiting
• First Posted: January 7, 2021
• Last Update Posted: January 22, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): ASAli, Assiut University

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.

Condition or disease	Intervention/treatment	Phase
Pre-Eclampsia	Other: Cardiovascular and immunological changes	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: April 1, 2022
• Estimated Study Completion Date: October 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: study group; new-born infants born from preeclampsia mother	Other: Cardiovascular and immunological changes; performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
control group; new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race	Other: Cardiovascular and immunological changes; performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample

Outcome Measures

Primary Outcome Measures :

1. Cardiac changes [ Time Frame: within 72 hours after birth ]
   cardiac output will be presented by ml/minute
2. Cardiac function changes [ Time Frame: within 72 hours after birth ]
   Fractional shortening and ejection fraction will be presented by percentage
3. 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

Secondary Outcome Measures :

1. Feeding problem [ Time Frame: 3 months after birth ]
   rate of necrotizing enterocolitis and feeding intolerance
2. oval all outcomes [ Time Frame: 3 months ]
   Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
3. immunological changes [ Time Frame: cord blood at birth ]
   interleukins level

Eligibility Criteria

• Ages Eligible for Study: up to 3 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Ahmed S Ali; 7309405405; ahmedsalehali@aun.edu.eg

Sponsors and Collaborators

Assiut University

More Information

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, Barnés 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. Review.

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.

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. Epub 2006 Apr 21. Review.

• Responsible Party: ASAli, Assistant lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04699825
• Other Study ID Numbers: cardiovascularpreeclampsia
• First Posted: January 7, 2021
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No, we will take consent from participant in this study only.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications