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

March 26, 2019 updated by: Cagdas Sahin, Ege University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey, 35100
        • Ege University, Medicine Faculty, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Collecting cervical liquid and sera samples
Normal intrauterine pregnancy group
This groups participants have normal intrauterine pregnancy
Other: Collecting cervical liquid and sera samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of Axonemal Dynein Heavy Chain 5
Time Frame: 1 year
1 year
Concentration of creatine kinase
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.101.2015.0076

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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