Ectopic PregnancyNCT02995356
Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
An observational study of Ectopic Pregnancy, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Collecting cervical liquid and sera samples
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2016to Nov 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who have doubt for ectopic pregnancy will be selected for study group and patients who have intrauterine pregnancy will be selected for control group.
Who may be able to join
- Doubted ectopic pregnancy
- Without any finding about intrauterine pregnancy in ultrasonography results
- Without any vaginal bleeding
- Having irregular pregnancy test results
- Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)
- Having fist trimester pregnancy for intrauterine pregnancy group
- Without any emergency findings
Who cannot join
- Doubted incomplete abortion
- Having vaginal bleeding
- Having ultrasound results which include intrauterine embryo report
- Having lower than 100 mIU/ml beta-HCG results
- Without fetal heart rate in intrauterine pregnancy group
- Having older than fist trimester pregnancy for intrauterine pregnancy group
- Having emergency findings
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Medicine Faculty, Department of Obstetrics and Gynecology
Izmir, 35100
About this study
Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.
- Conditions
- Ectopic Pregnancy
- Being tested
- Collecting cervical liquid and sera samples
- Keywords
- Ectopic pregnancy, Axonemal Dynein Heavy Chain 5, Creatine Kinase, Cervical fluid
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting cervical liquid and sera samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Doubt for ectopic pregnancy group | This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results. Receives: Other: Collecting cervical liquid and sera samples | |
| Normal intrauterine pregnancy group | This groups participants have normal intrauterine pregnancy Receives: Other: Collecting cervical liquid and sera samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Axonemal Dynein Heavy Chain 5
Measured: 1 year
Concentration of creatine kinase
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Sahin, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995356
- Sponsor's protocol ID
- 2.101.2015.0076
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2016
- Last updated
- 28 Mar 2019
- Results posted
- No
Publications
Sahin C, Uygun ZO, Hortu I, Akdemir A, Kocamanoglu M, Ergenoglu AM, Akcay Y. Using dynein heavy chain 5 and creatine kinase levels in cervical fluid and blood for early diagnosing of ectopic pregnancy. J Obstet Gynaecol Res. 2021 Mar;47(3):921-927. doi: 10.1111/jog.14616. Epub 2020 Dec 17.
PubMed 33336538
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT02995356
- Acronym / sponsor ID
- 2.101.2015.0076
- Conditions
- Ectopic Pregnancy
- Keywords
- Ectopic pregnancy, Axonemal Dynein Heavy Chain 5, Creatine Kinase, Cervical fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 16 Dec 2016 (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.
Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doubt for ectopic pregnancy group | – | Other: Collecting cervical liquid and sera samplesThis group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results. |
| Normal intrauterine pregnancy group | – | Other: Collecting cervical liquid and sera samplesThis groups participants have normal intrauterine pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have doubt for ectopic pregnancy will be selected for study group and patients who have intrauterine pregnancy will be selected for control group.
Key inclusion criteria (7 listed)
- Doubted ectopic pregnancy
- Without any finding about intrauterine pregnancy in ultrasonography results
- Without any vaginal bleeding
- Having irregular pregnancy test results
- Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)
Key exclusion criteria (7 listed)
- Doubted incomplete abortion
- Having vaginal bleeding
- Having ultrasound results which include intrauterine embryo report
- Having lower than 100 mIU/ml beta-HCG results
- Without fetal heart rate in intrauterine pregnancy group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting cervical liquid and sera samples | Other | Doubt for ectopic pregnancy group, Normal intrauterine pregnancy group |
Primary outcome
Concentration of Axonemal Dynein Heavy Chain 5
Time frame: 1 year
Concentration of creatine kinase
Time frame: 1 year
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 28 Mar 2019.
- Derived from this study: PubMed 33336538Sahin C, Uygun ZO, Hortu I, Akdemir A, Kocamanoglu M, Ergenoglu AM, Akcay Y. Using dynein heavy chain 5 and creatine kinase levels in cervical fluid and blood for early diagnosing of ectopic pregnancy. J Obstet Gynaecol Res. 2021 Mar;47(3):921-927. doi: 10.1111/jog.14616. Epub 2020 Dec 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ectopic Pregnancy, run by Ege University 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 7 inclusion and 7 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 28 Mar 2019. 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?
Concentration of Axonemal Dynein Heavy Chain 5 (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995356, which also lists 1 linked publication.
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 28 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.