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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05622838
Collaborator
(none)
160
25

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Alpha1 -Antitrypsin level

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Pregnant Pre-eclamptic women with IUGR at 32-36 weeks

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

Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks

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

Normal pregnant women with healthy fetus

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Omnia A Mohamed, Assistant professor, Clinical pathology department, Faculty of medicine, Assiut University, Egypt
  • Study Director: Yousra M Mamdouh, Lecturer, Clinical pathology department, Faculty of medicine, Assiut University, Egypt
  • Principal Investigator: Maryam E Eldreemy, Resident, Clinical pathology department, Faculty of medicine, Assiut University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maryam Elwany Eldreemy, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05622838
Other Study ID Numbers:
  • alpha1 antitrypsin as a marker
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 22, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 22, 2022