alpha1 Anti-trypsinNCT05622838
Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women
An observational study of alpha1 Anti-trypsin and Pre-Eclampsia, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- alpha1 Anti-trypsin, Pre-Eclampsia, Intrauterine Growth Restriction
- What is being tested?
- Alpha1 -Antitrypsin level
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women with pre-eclampsia
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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 .
- Being tested
- Alpha1 -Antitrypsin level
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pre-Eclampsia, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha1 -Antitrypsin levelDiagnostic test
measuring alpha1 -antitrypsin level in pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Pre-eclamptic women with IUGR at 32-36 weeks | Not described Receives: Diagnostic Test: Alpha1 -Antitrypsin level | |
| Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks | Not described Receives: Diagnostic Test: Alpha1 -Antitrypsin level | |
| Normal pregnant women with healthy fetus | Not described Receives: Diagnostic Test: Alpha1 -Antitrypsin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.
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
Measured: expected time of 2 years
Secondary outcomes (1)
Involvement of the results of this study in prediction and prevention of the disease.
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
Measured: expected time of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for alpha1 Anti-trypsinStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Elwany Eldreemy, Assiut University
- Investigators
- Omnia A Mohamed, Assistant professor, Study chair, Clinical pathology department, Faculty of medicine, Assiut University, EgyptYousra M Mamdouh, Lecturer, Study director, Clinical pathology department, Faculty of medicine, Assiut University, EgyptMaryam E Eldreemy, Resident, Principal investigator, Clinical pathology department, Faculty of medicine, Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622838
- Sponsor's protocol ID
- alpha1 antitrypsin as a marker
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12777538Hendrix 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.
PubMed 18482615Bendix 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.
PubMed 32351451Mol 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.
PubMed 26342729Nori 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.
PubMed 34571571
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women
- ClinicalTrials.gov ID
- NCT05622838
- Acronym / sponsor ID
- alpha1 antitrypsin as a marker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant Pre-eclamptic women with IUGR at 32-36 weeks | – | Diagnostic Test: Alpha1 -Antitrypsin level |
| Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks | – | Diagnostic Test: Alpha1 -Antitrypsin level |
| Normal pregnant women with healthy fetus | – | Diagnostic Test: Alpha1 -Antitrypsin level |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with pre-eclampsia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Multiple pregnancy.
- Congenital fetal anomalies.
- Pregnant women with personal history of chronic hypertension.
- Pregnant women with renal failure.
- Pregnant women with cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha1 -Antitrypsin levelmeasuring alpha1 -antitrypsin level in pregnant women | Diagnostic test | Normal pregnant women with healthy fetus, Pregnant Pre-eclamptic women with IUGR at 32-36 weeks, Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks |
Primary outcome
Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia.
Time frame: 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
1 secondary outcome
Involvement of the results of this study in prediction and prevention of the disease.
Time frame: expected time of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 12777538Lee 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.
- Background: PubMed 18482615Hendrix 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.
- Background: PubMed 32351451Bendix 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.
- Background: PubMed 26342729Mol 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.
- Background: PubMed 34571571Nori 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.
Related trials for alpha1 Anti-trypsin
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 1/2
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD)
RecruitingPhase 4
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
Alpha 1-Antitrypsin, COPD
Enrolling by invitationObservational study
AATD-Liver Scan Study
Alpha-1 Antitrypsin Deficiency, AATD
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omnia A Mohamed, Assistant professor study chair
Clinical pathology department, Faculty of medicine, Assiut University, Egypt
Yousra M Mamdouh, Lecturer study director
Clinical pathology department, Faculty of medicine, Assiut University, Egypt
Maryam E Eldreemy, Resident principal investigator
Clinical pathology department, Faculty of medicine, Assiut University, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of alpha1 Anti-trypsin and Pre-Eclampsia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam E Eldreemy, Resident (+201150885889, Maryamelwany123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of serum alpha-1 anti-trypsin levels during pregnancy and their relationship with intrauterine growth restriction and pre eclampsia. (time frame: expected time of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622838, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.