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Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy (VEGF)

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ClinicalTrials.gov Identifier: NCT01601964
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital

Brief Summary:

The aim of this study is to determine plasma Vascular Endothelial Growth Factor level and change in patient with ectopic pregnancy who needs to surgical treatment.

Patient with ectopic pregnancy diagnosed and treated with medically or surgically will be included in the study. This is an observational study.The plasma Vascular Endothelial Growth Factor level will be measured first day and two day after the diagnosis of ectopic pregnancy.


Condition or disease
Complication Following Ectopic Pregnancy

Detailed Description:

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with 30 patients with ectopic pregnancy. An intervenous cannula will be centrifuged for 15 minutes at 1000 g within 30 minutes of collection. Aliquots of plasma will be added to eppendorf tubes and stored at -20°C.

Plasma Vascular Endothelial Growth Factor levels will be measured using a Human VEGF-A Platinum ELISA kit (bioscience company, Catalog No: 00122, Santa Clara, California, USA). All assays will be performed according to the manufacturer's instructions. The test kit sensitivity is 2.5 pg/ml. Intracycle variability is %4-6, intercycle variability is %8-10.


Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
Study Start Date : May 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Follow-up or medical treatment.
medical treatment
Surgical treatment
Surgical treatment



Primary Outcome Measures :
  1. The primary Outcome Measure of this study is to determine plasma Vascular Endothelial Growth Factor cut-off level in patient with ectopic pregnancy who needs to surgical treatment. [ Time Frame: 3-4 months ]


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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients with ectopic pregnancy
Criteria

Inclusion Criteria:

  • Patients who suspected ectopic pregnancy

Exclusion Criteria:

  • hemodynamically unstable patient
  • healthy pregnancy (a healthy increase in ß HCG)
  • missed abortion
  • incomplete abortion
  • The patient who need immediate surgical treatment

Information from the National Library of Medicine

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): NCT01601964


Locations
Turkey
Bagcilar Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
Principal Investigator: TANER A USTA, M.D. Bagcilar Training and Research Hospital, Istanbul, Turkey.

Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01601964     History of Changes
Other Study ID Numbers: BEH GynObs-1
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Bagcilar Training and Research Hospital:
VEGF, ectopic pregnancy.

Additional relevant MeSH terms:
Pregnancy, Ectopic
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs