PreeclampsiaNCT03500588
Vascular Endothelial Factor Gene Polymorphism in Preeclampsia
An observational study of Preeclampsia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- PCR and Doppler ultrasound
- Type of treatment
- Medical device
- How many people
- 290 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Feb 2018
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: normal and preeclamptic pregnant women after 20 weeks were evaluated for VEGF gene polymorphism.
Who may be able to join
- More than 20 weeks gestation. Preeclamptic patients
Who cannot join
- association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension.
- association with auto-immune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Endothelial Growth Factor C/A 2578 Gene Polymorphism and Umbilical Artery Doppler in Preeclamptic Women
In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index of the umbilical artery.
Read the detailed description
Preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after 20 weeks of gestation. The pathophysiology of preeclampsia involves abnormalities in the development of placental vasculature early in pregnancy may result in relative placental under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal circulation that alter maternal endothelial function and cause hypertension and other manifestations of disease .Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. Human VEGF gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a family of proteins. There are several common single nucleotide polymorphisms (SNPs) in the VEGF gene, which could alter gene expression and protein production, and alter the risk of developing diseases characterized by deranged angiogenesis including preeclampsia.
- Conditions
- Preeclampsia
- Being tested
- PCR, Doppler ultrasound
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic test
Polymerase chain reaction was used to diagnose gene polymorphism.
Doppler ultrasoundDevice
Doppler ultrasound was used to assess the pulsatility index of the umbilical artery .
| Study group | Role | What they receive |
|---|---|---|
| normotensive pregnant women more than 20 weeks gestation. | One hundred and forty-five pregnant women after 20 weeks with normal blood pressure were evaluated for VEGF gene mutation. Receives: Diagnostic Test: PCR | |
| Pregnant women after 20 weeks with preeclampsia. | One hundred and forty-five pregnant women after 20 weeks with preeclampsia were evaluated for VEGF gene mutation by using PCR and Pulsitality index of umbilical artery by doppler velocimetry. Receives: Diagnostic Test: PCR; Device: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of VEGF gene mutation and preeclampsia
Is VEGF gene polymorphism associated with preeclampsia
Measured: from 20 weeks until delivery
Secondary outcomes (2)
fetal and neonatal outcomes
Intrauterine growth restriction
Measured: from 20 weeks until first postpartum week.
maternal outcome
Maternal admission to intensive care unit
Measured: from 20 weeks until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startJan 2017
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500588
- Sponsor's protocol ID
- BeniSuef 15
- Status last verified
- Mar 2021
- First submitted
- 10 Apr 2018
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA. 2002 Jun 26;287(24):3183-6. doi: 10.1001/jama.287.24.3183. No abstract available.
PubMed 12076198Huppertz B. Placental origins of preeclampsia: challenging the current hypothesis. Hypertension. 2008 Apr;51(4):970-5. doi: 10.1161/HYPERTENSIONAHA.107.107607. Epub 2008 Feb 7. No abstract available.
PubMed 18259009Cooper ME, Vranes D, Youssef S, Stacker SA, Cox AJ, Rizkalla B, Casley DJ, Bach LA, Kelly DJ, Gilbert RE. Increased renal expression of vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in experimental diabetes. Diabetes. 1999 Nov;48(11):2229-39. doi: 10.2337/diabetes.48.11.2229.
PubMed 10535459Chedraui P, Solis EJ, Bocci G, Gopal S, Russo E, Escobar GS, Hidalgo L, Perez-Lopez FR, Genazzani AR, Mannella P, Simoncini T. Feto-placental nitric oxide, asymmetric dimethylarginine and vascular endothelial growth factor (VEGF) levels and VEGF gene polymorphisms in severe preeclampsia. J Matern Fetal Neonatal Med. 2013 Feb;26(3):226-32. doi: 10.3109/14767058.2012.733760. Epub 2012 Oct 18.
PubMed 23039092
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Growth Factor C/A 2578 Gene Polymorphism and Umbilical Artery Doppler in Preeclamptic Women
- ClinicalTrials.gov ID
- NCT03500588
- Acronym / sponsor ID
- BeniSuef 15
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 Apr 2018 (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.
In this study, the investigators assessed one of the released protein factors during the pathophysiology of preeclampsia. They evaluated vascular endothelial growth factor gene mutation which affects the angiogenesis in case of inadequate placentation and its association with Doppler changes in the pulsatility index of the umbilical artery.
Detailed description
Preeclampsia is a syndrome characterized by occurrence of hypertension and proteinuria after 20 weeks of gestation. The pathophysiology of preeclampsia involves abnormalities in the development of placental vasculature early in pregnancy may result in relative placental under perfusion/hypoxia/ischemia, which then leads to release of factors into the maternal circulation that alter maternal endothelial function and cause hypertension and other manifestations of disease .Vascular endothelial growth factor (VEGF) is a signal protein produced by cells that stimulates vasculogenesis and angiogenesis. It is part of the system that restores the oxygen supply to tissues when blood circulation is inadequate. Human VEGF gene is located on chromosome 6 and consists of 8 exons with alternate splicing, forming a family of proteins. There are several common single nucleotide polymorphisms (SNPs) in the VEGF gene, which could alter gene expression and protein production, and alter the risk of developing diseases characterized by deranged angiogenesis including preeclampsia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normotensive pregnant women more than 20 weeks gestation. | – | Diagnostic Test: PCROne hundred and forty-five pregnant women after 20 weeks with normal blood pressure were evaluated for VEGF gene mutation. |
| Pregnant women after 20 weeks with preeclampsia. | – | Diagnostic Test: PCR, Device: Doppler ultrasoundOne hundred and forty-five pregnant women after 20 weeks with preeclampsia were evaluated for VEGF gene mutation by using PCR and Pulsitality index of umbilical artery by doppler velocimetry. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- normal and preeclamptic pregnant women after 20 weeks were evaluated for VEGF gene polymorphism.
Key inclusion criteria (1 listed)
- More than 20 weeks gestation. Preeclamptic patients
Key exclusion criteria (2 listed)
- association with chronic disease (cardiac, hepatic, renal) and if the patient was known to have chronic hypertension.
- association with auto-immune 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 |
|---|---|---|
| PCRPolymerase chain reaction was used to diagnose gene polymorphism. | Diagnostic test | Pregnant women after 20 weeks with preeclampsia., normotensive pregnant women more than 20 weeks gestation. |
| Doppler ultrasoundDoppler ultrasound was used to assess the pulsatility index of the umbilical artery . | Device | Pregnant women after 20 weeks with preeclampsia. |
Primary outcome
Correlation of VEGF gene mutation and preeclampsia
Time frame: from 20 weeks until delivery
Is VEGF gene polymorphism associated with preeclampsia
2 secondary outcomes
fetal and neonatal outcomes
Time frame: from 20 weeks until first postpartum week.
maternal outcome
Time frame: from 20 weeks until delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 12076198Lain KY, Roberts JM. Contemporary concepts of the pathogenesis and management of preeclampsia. JAMA. 2002 Jun 26;287(24):3183-6. doi: 10.1001/jama.287.24.3183. No abstract available.
- Background: PubMed 18259009Huppertz B. Placental origins of preeclampsia: challenging the current hypothesis. Hypertension. 2008 Apr;51(4):970-5. doi: 10.1161/HYPERTENSIONAHA.107.107607. Epub 2008 Feb 7. No abstract available.
- Background: PubMed 10535459Cooper ME, Vranes D, Youssef S, Stacker SA, Cox AJ, Rizkalla B, Casley DJ, Bach LA, Kelly DJ, Gilbert RE. Increased renal expression of vascular endothelial growth factor (VEGF) and its receptor VEGFR-2 in experimental diabetes. Diabetes. 1999 Nov;48(11):2229-39. doi: 10.2337/diabetes.48.11.2229.
- Background: PubMed 23039092Chedraui P, Solis EJ, Bocci G, Gopal S, Russo E, Escobar GS, Hidalgo L, Perez-Lopez FR, Genazzani AR, Mannella P, Simoncini T. Feto-placental nitric oxide, asymmetric dimethylarginine and vascular endothelial growth factor (VEGF) levels and VEGF gene polymorphisms in severe preeclampsia. J Matern Fetal Neonatal Med. 2013 Feb;26(3):226-32. doi: 10.3109/14767058.2012.733760. Epub 2012 Oct 18.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
RecruitingEarly Phase 1
Antidepressant Therapy for Improved Blood Vessel Health After Preeclampsia
Preeclampsia, Endothelial Function
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruitingEarly Phase 1
Daily Aspirin Treatment After Preeclampsia
Preeclampsia
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Beni-Suef University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of VEGF gene mutation and preeclampsia (time frame: from 20 weeks until delivery). 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 NCT03500588, which also lists 4 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 26 Mar 2021.