Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01601964
Other study ID # BEH GynObs-1
Secondary ID
Status Completed
Phase N/A
First received May 17, 2012
Last updated August 6, 2015
Start date May 2012
Est. completion date February 2013

Study information

Verified date August 2015
Source Bagcilar Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 46 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bagcilar Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3-4 months No