NCT02973230

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 Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations).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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

11 months

First QC Date

November 22, 2016

Last Update Submit

November 23, 2016

Conditions

Keywords

Pregnancy, EctopicVascular Endothelial Growth Factor APregnancy, Tubal

Outcome Measures

Primary Outcomes (1)

  • VEGF serum concentration

    One year

Interventions

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • non-ampullar tubal pregnancy (surgically confirmed).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo - School of Medicine - General Hospital

São Paulo, São Paulo, 05403010, Brazil

Location

MeSH Terms

Conditions

Pregnancy, EctopicPregnancy, Tubal

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; MSc, PhD

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations