Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy

NCT ID: NCT02995356

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ectopic Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Collecting cervical liquid and sera samples

Intervention Type OTHER

Normal intrauterine pregnancy group

This groups participants have normal intrauterine pregnancy

Collecting cervical liquid and sera samples

Intervention Type OTHER

Interventions

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Collecting cervical liquid and sera samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Cagdas Sahin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University, Medicine Faculty, Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33336538 (View on PubMed)

Other Identifiers

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2.101.2015.0076

Identifier Type: -

Identifier Source: org_study_id

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