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

Not yet recruiting

• Conditions: Pre-Eclampsia; Intrauterine Growth Restriction; alpha1 Anti-trypsin
• Interventions: Diagnostic Test: Alpha1 -Antitrypsin level

• Registration Number: NCT05622838
• Lead Sponsor: Assiut University

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-18
• Study First Posted: 2022-11-21
• Last Update Posted: 2022-11-22
• Study Start: 2022-12
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal pregnant women with healthy fetus	Alpha1 -Antitrypsin level	-
Pregnant Pre-eclamptic women with IUGR at 32-36 weeks	Alpha1 -Antitrypsin level	-
Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks	Alpha1 -Antitrypsin level	-

Primary Outcome Measures

Name	Time	Method
Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.	expected time of 2 years	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

Secondary Outcome Measures

Name	Time	Method
Involvement of the results of this study in prediction and prevention of the disease.	expected time of 2 years	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