Serum VEGF as a Tubal Pregnancy Marker
Primary Purpose
Pregnancy, Ectopic
Status
Completed
Phase
Locations
Brazil
Study Type
Observational
Intervention
Dosage of VEGF serum concentration
Sponsored by
About this trial
This is an observational trial for Pregnancy, Ectopic focused on measuring Pregnancy, Ectopic, Vascular Endothelial Growth Factor A, Pregnancy, Tubal
Eligibility Criteria
Inclusion Criteria were:
- women that had a positive hCG test and presented with either abdominal pain or vaginal bleeding; all pregnancies were singletons, spontaneously conceived, with accurate assessments of their gestational age (42 - 56 days from the first day of the last menstrual period). A detailed informed consent was obtained from each patient before the inclusion.
Exclusion Criteria was:
- non-ampullar tubal pregnancy (surgically confirmed).
Sites / Locations
- University of Sao Paulo - School of Medicine - General Hospital
Outcomes
Primary Outcome Measures
VEGF serum concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT02973230
First Posted
November 22, 2016
Last Updated
November 23, 2016
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02973230
Brief Title
Serum VEGF as a Tubal Pregnancy Marker
Official Title
Serum Vascular Endothelial Growth Factor (VEGF) As a Marker for Tubal Pregnancy
Study Type
Observational
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
5. Study Description
Brief Summary
The aim of the present study was (i) to evaluate whether a single measurement of VEGF would allow us to distinguish between intrauterine pregnancy (normal and abnormal) and EP and (ii) to correlate the levels of VEGF with serum levels of progesterone and β-hCG in each subgroup.
Ninety patients were selected from a population of women presenting to the Hospital das Clínicas of the University of São Paulo Medical School from October 2006 until September 2007 and were divided in three subgroups: (i) abnormal (arrested) intrauterine pregnancy (defined as a gestational sac greater than 16 mm of mean diameter without fetal tissue or a embryo greater than 5 mm without embryo cardiac activity); (ii) tubal pregnancy (no evidence of intrauterine pregnancy, presence of a adnexal mass, suboptimal rise of serum hCG levels in 48 hours); all tubal pregnancies were surgically treated and were histologically confirmed, they did not receive any methotrexate treatment before operation; (iii) normal intrauterine pregnancy (intrauterine gestational sac, embryo vitality confirmed).
Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Ectopic
Keywords
Pregnancy, Ectopic, Vascular Endothelial Growth Factor A, Pregnancy, Tubal
7. Study Design
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Dosage of VEGF serum concentration
Intervention Description
Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.
Primary Outcome Measure Information:
Title
VEGF serum concentration
Time Frame
One year
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria were:
women that had a positive hCG test and presented with either abdominal pain or vaginal bleeding; all pregnancies were singletons, spontaneously conceived, with accurate assessments of their gestational age (42 - 56 days from the first day of the last menstrual period). A detailed informed consent was obtained from each patient before the inclusion.
Exclusion Criteria was:
non-ampullar tubal pregnancy (surgically confirmed).
Facility Information:
Facility Name
University of Sao Paulo - School of Medicine - General Hospital
City
Sao Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
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Serum VEGF as a Tubal Pregnancy Marker
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