Clinical trial NCT05622838: Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women
Official title: Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: alpha1 Anti-trypsin
Pre-Eclampsia
Intrauterine Growth Restriction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with pre-eclampsia

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.
timeFrame: expected time of 2 years
Secondary outcomes:
measure: Involvement of the results of this study in prediction and prevention of the disease.
timeFrame: expected time of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Clinical pathology department, Faculty of medicine, Assiut University, Egypt
name: Omnia A Mohamed, Assistant professor
role: STUDY_CHAIR
affiliation: Clinical pathology department, Faculty of medicine, Assiut University, Egypt
name: Yousra M Mamdouh, Lecturer
role: STUDY_DIRECTOR
affiliation: Clinical pathology department, Faculty of medicine, Assiut University, Egypt
name: Maryam E Eldreemy, Resident
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1542/peds.111.6.1253.
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.
citation: 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.
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.
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.