Foetal Growth RestrictionVEGF in FGRNCT02245477
Maternal Serum Vascular Endothelial Growth Factor in Pregnant Women With Foetal Growth Restriction
An observational study of Foetal Growth Restriction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
In this study we explore To explore the role of maternal serum vascular endothelial growth factor (VEGF) in pregnancies complicated by foetal growth restriction. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Foetal Growth Restriction
- What is being tested?
- obstetric Ultrasound and serum Vascular Endothelial Growth Factor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Jun 2021
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile.Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had faltered.
Who may be able to join
- Age 20-40 years
- Gestational age 28-36 weeks
- Fetal growth restriction
- Patient consents to the procedure.
- BMI 20-30
Who cannot join
- Preeclampsia
- Diabetes Mellitus
- Fetal congenital anomalies
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nesreen Abdel Fattah Abdullah Shehata
Cairo
Nesreen A Shehata, MD, 00201024150605, nesoomar@yahoo.com
Nesreen A Shehata, MD
About this study
Official title: Evaluation of Maternal Serum VEGF in Pregnant Women With Foetal Growth Restriction
In this study we explore To explore the role of maternal serum vascular endothelial growth factor (VEGF) in pregnancies complicated by foetal growth restriction.
Read the detailed description
Small-for-gestational age (SGA) is defined as an estimated foetal weight (EFW) or abdominal circumference (AC) less than the 10th centileand severe SGA as an EFW or AC less than the 3rd centile. Foetal Growth Restriction refers to failure of the foetus to achieve its predetermined growth potential for various reasons.Foetus with foetal growth restriction (FGR) greatly contributes to perinatal mortality and short- and long-term morbidity. There is a 3-10 fold increase in perinatal mortality in pregnancies complicated by this FGR .The incidence of FGR in newborns ranges between 3 and 7% of the total population .FGR is thought to stem from placental hypoxia-induced vasoconstriction of the fetoplacental vessels, leading to placental hypoperfusion and thus fetal undernutrition. However, the effects of hypoxia on the fetoplacental vessels have been surprisingly little studied.Vascular endothelial growth factor (VEGF) is one of the factors that take part in placental angiogenesis. It is highly expressed during embryonic and foetal development..Angiogenesis involves the branching of new microvessles from pre-existing larger blood vessels.Angiogenesis plays a role in the development of the villous vasculature and the formation of terminal villi in human placenta. IUGR occurs as a result of the failure of elongation, branching and dilatation of the capillary loops and of terminal villous formation.
- Conditions
- Foetal Growth Restriction
- Being tested
- obstetric Ultrasound, serum Vascular Endothelial Growth Factor
- Keywords
- Serum VEGF, FGR
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obstetric UltrasoundDevice
Transabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta.
serum Vascular Endothelial Growth FactorOther
Maternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees
| Study group | Role | What they receive |
|---|---|---|
| Obstetric Ultrasoud | Transabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta. Receives: Device: obstetric Ultrasound | |
| Serum Vascular Endothelial Growth Factor | Serum VEGF concentration will be determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R \& D Systems, Inc , (Minneapolis, MN, USA). Receives: Other: serum Vascular Endothelial Growth Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric ultrasound
Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile. Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had altered.
Measured: from 28 weeks gestation to 36 weeks gestation
Secondary outcomes (1)
Serum Vascular Endothelial growth factor
Maternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees.Serum VEGF concentration was determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R \& D Systems, Inc , (Minneapolis, MN, USA).
Measured: 3 months until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foetal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 100 participants (estimated)
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
- NCT02245477
- Sponsor's protocol ID
- Beni-Suef 5
- Acronym
- VEGF in FGR
- Status last verified
- Jan 2021
- First submitted
- 17 Sep 2014
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal Serum VEGF in Pregnant Women With Foetal Growth Restriction
- ClinicalTrials.gov ID
- NCT02245477
- Acronym / sponsor ID
- VEGF in FGR / Beni-Suef 5
- Conditions
- Foetal Growth Restriction
- Keywords
- Serum VEGF, FGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- 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 we explore To explore the role of maternal serum vascular endothelial growth factor (VEGF) in pregnancies complicated by foetal growth restriction.
Detailed description
Small-for-gestational age (SGA) is defined as an estimated foetal weight (EFW) or abdominal circumference (AC) less than the 10th centileand severe SGA as an EFW or AC less than the 3rd centile. Foetal Growth Restriction refers to failure of the foetus to achieve its predetermined growth potential for various reasons.Foetus with foetal growth restriction (FGR) greatly contributes to perinatal mortality and short- and long-term morbidity. There is a 3-10 fold increase in perinatal mortality in pregnancies complicated by this FGR .The incidence of FGR in newborns ranges between 3 and 7% of the total population .FGR is thought to stem from placental hypoxia-induced vasoconstriction of the fetoplacental vessels, leading to placental hypoperfusion and thus fetal undernutrition. However, the effects of hypoxia on the fetoplacental vessels have been surprisingly little studied.Vascular endothelial growth factor (VEGF) is one of the factors that take part in placental angiogenesis. It is highly expressed during embryonic and foetal development..Angiogenesis involves the branching of new microvessles from pre-existing larger blood vessels.Angiogenesis plays a role in the development of the villous vasculature and the formation of terminal villi in human placenta. IUGR occurs as a result of the failure of elongation, branching and dilatation of the capillary loops and of terminal villous formation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstetric Ultrasoud | – | Device: obstetric UltrasoundTransabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta. |
| Serum Vascular Endothelial Growth Factor | – | Other: serum Vascular Endothelial Growth FactorSerum VEGF concentration will be determined by Enzyme Linked immunosorbant assay using Quantitative Human VEGF Immunoassay kit (cat. No. DVEOO) manufactured by R \& D Systems, Inc , (Minneapolis, MN, USA). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile.Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had faltered.
Key inclusion criteria (5 listed)
- Age 20-40 years
- Gestational age 28-36 weeks
- Fetal growth restriction
- Patient consents to the procedure.
- BMI 20-30
Key exclusion criteria (3 listed)
- Preeclampsia
- Diabetes Mellitus
- Fetal congenital anomalies
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 |
|---|---|---|
| obstetric UltrasoundTransabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta. | Device | Obstetric Ultrasoud |
| serum Vascular Endothelial Growth FactorMaternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees | Other | Serum Vascular Endothelial Growth Factor |
Primary outcome
Obstetric ultrasound
Time frame: from 28 weeks gestation to 36 weeks gestation
Patients with gestational age 28-36 weeks were included in our study. Patients with SGA were defined by obstetric ultrasound as estimated fetal weight was below the10thcentile. Twice weekly CTGs and Umbilical artery (UA) Doppler were done. Women with abnormal CTGs or UA Doppler were excluded from the study. A follow up scan was done 2 weeks later and FGR will be diagnosed if fetal weight had altered.
1 secondary outcome
Serum Vascular Endothelial growth factor
Time frame: 3 months until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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.
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 Foetal Growth Restriction, 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 5 inclusion and 3 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 2 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201227866337, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric ultrasound (time frame: from 28 weeks gestation to 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.