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

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ClinicalTrials.gov Identifier: NCT01261026
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:

Study Description
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%.


Condition or disease
Ectopic Pregnancy

Study Design

Study Type : Observational
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Are Serum Levels of Vascular Endothelial Growth Factor a Marker for the Early Diagnosis of Ectopic Pregnancy?

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Ectopic pregnancy, extra-uterine pregnancy
Ectopic pregnancy, control
Abnormal intrauterine pregnancy


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
ectopic pregnancy abnormal intrauterine pregnancy normal intrauterine pregnancy
Criteria

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).

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261026


Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo