Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women

NCT05622838 | Unknown

• 1 other identifier: alpha1 antitrypsin as a marker
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intrauterine growth restriction (IUGR) is defined as a velocity of fetal growth less than the normal fetus growth potential for a specific neonate as per the race and gender. These neonates face many acute problems during peripartum and after birth .The causes of IUGR may be maternal, placental, fetal or genetic and also due to combination of any of these factors. Knowledge of etiologies of fetal growth restriction (FGR) is essential, so that future care can be targeted at prevention . It is apparent that FGR is primarily caused by placental dysfunction (PIH\&PE), insufficiency that lead to reduced fetal growth overall. FGR is associated with lifelong burden of chronic diseases including metabolic, respiratory, cardiovascular and neurological deficits. Pre-eclampsia (PE) is diagnosed by the combined presentation of high blood pressure and proteinuria. New definitions also include maternal organ dysfunction, such as renal, liver, neurological or haematological complications, uteroplacental dysfunction, or FGR . In an attempt to correct fetus reduced supply the placenta release various cytokines and markers as Alpha-1 anti-trypsin (AAT). The Golgi apparatus secretes this cytokine in placental cytotrophoblast and blood vessels. AAT is antinflammatory antiprotease protective molecule. AAT rises during normal pregnancy. The suboptimal rise of AAT in pregnancy are liable for increased obstetrical complications like abortion, preterm labor. AAT levels were found decreased in placenta tissues from women with PE compared that of healthy women. Although AAT deficiency is associated with several pregnancy and placental disorders, little is known regarding AAT levels and PE .

Conditions

alpha1 Anti-trypsin; Pre-Eclampsia; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.

  The levels of alpha-1 anti-trypsin will be measured in pregnant women and then will be correlated with the occurence of pre-eclampsia and intrauterine growth restriction

  expected time of 2 years

Secondary Outcomes (1)

• Involvement of the results of this study in prediction and prevention of the disease.

  expected time of 2 years

Study Arms (3)

Pregnant Pre-eclamptic women with IUGR at 32-36 weeks

Diagnostic Test: Alpha1 -Antitrypsin level

Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks

Diagnostic Test: Alpha1 -Antitrypsin level

Normal pregnant women with healthy fetus

Diagnostic Test: Alpha1 -Antitrypsin level

Interventions

Alpha1 -Antitrypsin level DIAGNOSTIC_TEST

measuring alpha1 -antitrypsin level in pregnant women

Normal pregnant women with healthy fetus; Pregnant Pre-eclamptic women with IUGR at 32-36 weeks; Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with pre-eclampsia

You may qualify if:

• Pregnant Pre-eclamptic women with IUGR at 32-36 weeks
• Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks
• Normal pregnant women with healthy fetus

You may not qualify if:

• Multiple pregnancy.
• Congenital fetal anomalies.
• Pregnant women with personal history of chronic hypertension.
• Pregnant women with renal failure.
• Pregnant women with cardiovascular disease.
• Pregnant women with diabetes mellitus.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Lee PA, Chernausek SD, Hokken-Koelega AC, Czernichow P; International Small for Gestational Age Advisory Board. International Small for Gestational Age Advisory Board consensus development conference statement: management of short children born small for gestational age, April 24-October 1, 2001. Pediatrics. 2003 Jun;111(6 Pt 1):1253-61. doi: 10.1542/peds.111.6.1253.

  PMID: 12777538 BACKGROUND

• Hendrix N, Berghella V. Non-placental causes of intrauterine growth restriction. Semin Perinatol. 2008 Jun;32(3):161-5. doi: 10.1053/j.semperi.2008.02.004.

  PMID: 18482615 BACKGROUND

• Bendix I, Miller SL, Winterhager E. Editorial: Causes and Consequences of Intrauterine Growth Restriction. Front Endocrinol (Lausanne). 2020 Apr 15;11:205. doi: 10.3389/fendo.2020.00205. eCollection 2020. No abstract available.

  PMID: 32351451 BACKGROUND

• Mol BWJ, Roberts CT, Thangaratinam S, Magee LA, de Groot CJM, Hofmeyr GJ. Pre-eclampsia. Lancet. 2016 Mar 5;387(10022):999-1011. doi: 10.1016/S0140-6736(15)00070-7. Epub 2015 Sep 2.

  PMID: 26342729 BACKGROUND

• Nori W, Ali AI. Maternal alpha-1-antitrypsin as a noval marker for growth restriction in pre-eclampsia. J Obstet Gynaecol Res. 2021 Dec;47(12):4250-4255. doi: 10.1111/jog.15043. Epub 2021 Sep 27.

  PMID: 34571571 BACKGROUND

MeSH Terms

Conditions

alpha 1-Antitrypsin Deficiency; Pre-Eclampsia; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Growth Disorders

Study Officials

• Omnia A Mohamed, Assistant professor

  Clinical pathology department, Faculty of medicine, Assiut University, Egypt

  STUDY CHAIR

• Yousra M Mamdouh, Lecturer

  Clinical pathology department, Faculty of medicine, Assiut University, Egypt

  STUDY DIRECTOR

• Maryam E Eldreemy, Resident

  Clinical pathology department, Faculty of medicine, Assiut University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam E Eldreemy, Resident

CONTACT

+201150885889; Maryamelwany123@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 21, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 22, 2022

Record last verified: 2022-11