NCT02245477

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

6.8 years

First QC Date

September 17, 2014

Last Update Submit

January 30, 2021

Conditions

Keywords

Serum VEGF, FGR

Outcome Measures

Primary Outcomes (1)

  • 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.

    from 28 weeks gestation to 36 weeks gestation

Secondary Outcomes (1)

  • Serum Vascular Endothelial growth factor

    3 months until delivery

Study Arms (2)

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.

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).

Other: serum Vascular Endothelial Growth Factor

Interventions

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.

Obstetric Ultrasoud

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 Vascular Endothelial Growth Factor

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age 20-40 years
  • Gestational age 28-36 weeks
  • Fetal growth restriction
  • Patient consents to the procedure.
  • BMI 20-30

You may not qualify if:

  • Preeclampsia
  • Diabetes Mellitus
  • Fetal congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesreen Abdel Fattah Abdullah Shehata

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nesreen A Shehata, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations