Cardiovascular Changes in Infants of Preeclampsia Mother

NCT04699825 | Unknown

• 1 other identifier: cardiovascularpreeclampsia
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (3)

• Cardiac changes

  cardiac output will be presented by ml/minute

  within 72 hours after birth

• Cardiac function changes

  Fractional shortening and ejection fraction will be presented by percentage

  within 72 hours after birth

• 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

  72 hours after birth

Secondary Outcomes (3)

• Feeding problem

  3 months after birth

• oval all outcomes

  3 months

• immunological changes

  cord blood at birth

Study Arms (2)

study group

ACTIVE COMPARATOR

new-born infants born from preeclampsia mother

Other: Cardiovascular and immunological changes

control group

OTHER

new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race

Other: Cardiovascular and immunological changes

Interventions

Cardiovascular and immunological changes OTHER

performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample

control group; study group

Eligibility Criteria

• Age: 1 Minute - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born from Pregnant women with preeclampsia, their mother willing to give consent.

You may not qualify if:

• Infant with a major heart problem.
• Infants with major congenital and genetic anomalies.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 24201165 BACKGROUND

• 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.

  PMID: 20004912 BACKGROUND

• 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.

  PMID: 29113524 BACKGROUND

• 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.

  PMID: 14986803 BACKGROUND

• 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.

  PMID: 16813742 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Circulation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Ahmed S Ali

CONTACT

7309405405; ahmedsalehali@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share