Serum VEGF as a Tubal Pregnancy Marker

Pregnancy, Ectopic Clinical Trial

Official title:

Serum Vascular Endothelial Growth Factor (VEGF) As a Marker for Tubal Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973230
• Other study ID #: fcabarVEGF1
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: November 23, 2016
• Start date: October 2006
• Est. completion date: September 2007

Study information

• Verified date: November 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Study Design

N/A

Related Conditions & MeSH terms

• Pregnancy, Ectopic

Intervention

Other:
• Dosage of VEGF serum concentration
Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for ß-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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - School of Medicine - General Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF serum concentration		One year	No