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

Completed

• Conditions: Ectopic Pregnancy

• Registration Number: NCT01261026
• Lead Sponsor: Federal University of São Paulo

Brief 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%.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-15
• Last Update Submitted: 2010-12-15
• Study First Posted: 2010-12-16
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil