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

Completed

• Conditions: Ectopic Pregnancy
• Interventions: Other: Collecting cervical liquid and sera samples

• Registration Number: NCT02995356
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-16
• Primary Completion: 2018-06
• Study Completion: 2018-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal intrauterine pregnancy group	Collecting cervical liquid and sera samples	This groups participants have normal intrauterine pregnancy
Doubt for ectopic pregnancy group	Collecting cervical liquid and sera samples	This group participants have doubt for ectopic pregnancy in terms of beta-HCG pregnancy follow-up results and ultrasonography results.

Primary Outcome Measures

Name	Time	Method
Concentration of Axonemal Dynein Heavy Chain 5	1 year
Concentration of creatine kinase	1 year

Trial Locations

Locations (1)

Ege University, Medicine Faculty, Department of Obstetrics and Gynecology; 🇹🇷 Izmir, Turkey