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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05622838
• Other study ID #: alpha1 antitrypsin as a marker
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: January 2025

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: Maryam E Eldreemy, Resident
• Phone: +201150885889
• Email: Maryamelwany123[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alpha 1-Antitrypsin Deficiency
• Eclampsia
• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Pre-Eclampsia

Intervention

Diagnostic Test:
• Alpha1 -Antitrypsin level
measuring alpha1 -antitrypsin level in pregnant women

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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