Trial record 1 of 50 for:    ectopic pregnancy
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Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy (VEGF)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01601964
First received: May 17, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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
Complication Following Ectopic Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy

Resource links provided by NLM:


Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Follow-up or medical treatment.
medical treatment
Surgical treatment
Surgical treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01601964     History of Changes
Other Study ID Numbers: BEH GynObs-1
Study First Received: May 17, 2012
Last Updated: February 12, 2013
Health Authority: Turkey: Ministry of Health

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
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014