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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05622838
Enrollment
160
Registered
2022-11-21
Start date
2022-12-31
Completion date
2025-01-31
Last updated
2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alpha1 Anti-trypsin, Intrauterine Growth Restriction, 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 .

Interventions

DIAGNOSTIC_TESTAlpha1 -Antitrypsin level

measuring alpha1 -antitrypsin level in pregnant women

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.expected time of 2 yearsThe 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

MeasureTime frameDescription
Involvement of the results of this study in prediction and prevention of the disease.expected time of 2 yearsThe 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

Contacts

Primary ContactMaryam E Eldreemy, Resident
Maryamelwany123@gmail.com+201150885889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026