Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?

Ectopic Pregnancy Clinical Trial

— UNIFESP  

Official title:

Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261026
• Other study ID #: JEJ-060866
• Status: Completed
• Phase: N/A
• First received: December 15, 2010
• Last updated: December 15, 2010

Study information

• Verified date: December 2007
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

OBJECTIVE: This study evaluated serum vascular endothelial growth factor (VEGF) concentrations in women with ectopic pregnancy (EP), abnormal intrauterine pregnancy (aIUP) and normal intrauterine pregnancy (nIUP).

METHODS: This was a prospective, case-control study comparing serum VEGF concentrations among 72 women with ectopic pregnancy (n=35), abnormal IUP (n=15) and normal IUP (n=22) matched for gestational age. For the determination of serum VEGF concentration a solid phase sandwich ELISA was used. Patients were stratified according to serum VEGF above or below 200pg/mL.

RESULTS: The serum level of VEGF was significantly higher in women with ectopic pregnancy (median 211.1 pg/mL; range 5 - 1017.0 pg/mL) than in women with normal IUP (median 5 pg/mL; range 5- 310.6 pg/mL) P < 0.0001. Serum VEGF concentrations did not show any statistically significant difference between women with aIUP (median 231.9 pg/mL range 5 - 813.7 pg /mL ) and EP (median 211.1 pg/mL range 5 - 1017.0 pg/mL). When cut-off concentrations of 200 pg/mL for VEGF were used, a nIUP could be distinguished from an unviable (EP and aIUP) with a sensitive of 53%, specificity of 90.9%, a positive predictive value of 92.9% and a negative predictive value of 46.5%..

CONCLUSIONS: Serum VEGF could not distinguish between an EP and an aIUP. However, serum VEGF concentrations above 200 pg/mL could discriminate a nIUP from an unviable pregnancy (EP or aIUP) with a PPV of 92.9%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:The inclusion criterion was the presence at transvaginal ultrasound of an extraovarian adnexal mass in women with a suspected ectopic pregnancy (amenorrhea, bleeding and pain) with positive test for beta-hCG.

Exclusion Criteria:The exclusion criterion was non-tubal ectopic pregnancy (cervical, cesarean scar, ovarian, and abdominal).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Daponte A, Pournaras S, Zintzaras E, Kallitsaris A, Lialios G, Maniatis AN, Messinis IE. The value of a single combined measurement of VEGF, glycodelin, progesterone, PAPP-A, HPL and LIF for differentiating between ectopic and abnormal intrauterine pregna — View Citation

Ugurlu EN, Ozaksit G, Karaer A, Zulfikaroglu E, Atalay A, Ugur M. The value of vascular endothelial growth factor, pregnancy-associated plasma protein-A, and progesterone for early differentiation of ectopic pregnancies, normal intrauterine pregnancies, a — View Citation