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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Pre-Eclampsia; Intrauterine Growth Restriction; alpha1 Anti-trypsin
• Intervention / Treatment: Diagnostic test: Alpha1 -Antitrypsin level

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Maryam E Eldreemy, Resident; Phone Number: +201150885889; Email: Maryamelwany123@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with pre-eclampsia

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Pre-eclamptic women with IUGR at 32-36 weeks	Diagnostic test: Alpha1 -Antitrypsin level; measuring alpha1 -antitrypsin level in pregnant women
Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks	Diagnostic test: Alpha1 -Antitrypsin level; measuring alpha1 -antitrypsin level in pregnant women
Normal pregnant women with healthy fetus	Diagnostic test: Alpha1 -Antitrypsin level; measuring alpha1 -antitrypsin level in pregnant women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Involvement of the results of this study in prediction and prevention of the disease.	The results that the investigators will get will be used as predictors and even preventers of intrauterine growth restriction which is a major problem threatening babies born to pre-eclamptic women	expected time of 2 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Omnia A Mohamed, Assistant professor, Clinical pathology department, Faculty of medicine, Assiut University, Egypt; Study Director: Yousra M Mamdouh, Lecturer, Clinical pathology department, Faculty of medicine, Assiut University, Egypt; Principal Investigator: Maryam E Eldreemy, Resident, Clinical pathology department, Faculty of medicine, Assiut University, Egypt

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (ACTUAL): November 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Liver Diseases; Genetic Diseases, Inborn; Fetal Diseases; Pregnancy Complications; Subcutaneous Emphysema; Hypertension, Pregnancy-Induced; Growth Disorders; Emphysema; Alpha 1-Antitrypsin Deficiency; Eclampsia; Pre-Eclampsia; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Alpha 1-Antitrypsin; Protein C Inhibitor
• Other Study ID Numbers: alpha1 antitrypsin as a marker

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No