Complication Following Ectopic PregnancyVEGFNCT01601964
Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
An observational study of Complication Following Ectopic Pregnancy, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Complication Following Ectopic Pregnancy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2012to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients with ectopic pregnancy
Who may be able to join
- Patients who suspected ectopic pregnancy
Who cannot join
- hemodynamically unstable patient
- healthy pregnancy (a healthy increase in ß HCG)
- missed abortion
- incomplete abortion
- The patient who need immediate surgical treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul
About this study
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.
Read the 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.
- Conditions
- Complication Following Ectopic Pregnancy
- Keywords
- VEGF, ectopic pregnancy.
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up or medical treatment. | medical treatment | |
| Surgical treatment | Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication Following Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- TANER A USTA, M.D., Principal investigator, Bagcilar Training and Research Hospital, Istanbul, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601964
- Sponsor's protocol ID
- BEH GynObs-1
- Acronym
- VEGF
- Status last verified
- Aug 2015
- First submitted
- 17 May 2012
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Endothelial Growth Factor Levels in Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT01601964
- Acronym / sponsor ID
- VEGF / BEH GynObs-1
- Conditions
- Complication Following Ectopic Pregnancy
- Keywords
- VEGF, ectopic pregnancy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- May 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up or medical treatment. | – | –medical treatment |
| Surgical treatment | – | –Surgical treatment |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients with ectopic pregnancy
Key inclusion criteria (1 listed)
- Patients who suspected ectopic pregnancy
Key exclusion criteria (5 listed)
- hemodynamically unstable patient
- healthy pregnancy (a healthy increase in ß HCG)
- missed abortion
- incomplete abortion
- The patient who need immediate surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TANER A USTA, M.D. principal investigator
Bagcilar Training and Research Hospital, Istanbul, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication Following Ectopic Pregnancy, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.