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

NCT02995356 | Completed

• 1 other identifier: 2.101.2015.0076
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Ectopic pregnancy; Axonemal Dynein Heavy Chain 5; Creatine Kinase; Cervical fluid

Outcome Measures

Primary Outcomes (2)

• Concentration of Axonemal Dynein Heavy Chain 5

  1 year

• Concentration of creatine kinase

  1 year

Study Arms (2)

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

Interventions

Collecting cervical liquid and sera samples OTHER

Doubt for ectopic pregnancy group; Normal intrauterine pregnancy group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Medicine Faculty, Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33336538 DERIVED

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 16, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

TU (1)