A new observational case-control study sponsored by Assiut University will investigate maternal alpha-1 antitrypsin (AAT) as a potential marker of intrauterine growth restriction in pre-eclamptic women.
This study follows observations suggesting a link between AAT deficiency (AATD) and several pregnancy and placental disorders.
The study is expected to start December 2022 and will enroll 160 pregnant women with or without pre-eclampsia (the study is not yet recruiting) distributed by 3 groups as follows: pregnant pre-eclamptic women with intrauterine growth restriction at 32 to 36 weeks, pregnant pre-eclamptic women with healthy fetus at 32 to 36 weeks, and normal pregnant women with healthy fetus.
The primary endpoint of the study is the assessment of serum AAT levels during pregnancy and the relationship with intrauterine growth restriction and pre-eclampsia. In addition, the results of the study will be used to predict and even prevent intrauterine growth restriction.
Read more about AATD diagnosis
Pregnant women with personal history of chronic hypertension, renal failure, cardiovascular disease, or diabetes mellitus are excluded from the study. Multiple pregnancies and congenital fetal anomalies are also exclusion criteria.
This will be a 2-year study. Estimated primary completion date is December 2024 and estimated study completion date is January 2025.
AAT is an anti-inflammatory anti-protease protective molecule that is secreted by the placenta in a normal pregnancy. Therefore, increased AAT during pregnancy is physiological. The suboptimal rise of AAT in pregnancy has been associated with increased obstetrical complications, including abortion and preterm labor.
Read more about AATD etiology
Intrauterine growth restriction can have a maternal, placental, fetal, and/or genetic origin. Preventing intrauterine growth restriction is essential as it is associated with many acute problems for neonates during peripartum and after birth, as well as with lifelong burden of chronic diseases such as AATD.
Maternal alpha1 antitrypsin as a marker of intrauterine growth restriction in pre-eclamptic women. ClinicalTrials.gov. November 21, 2022. Updated November 22, 2022. Accessed November 23, 2022.