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

Ectopic Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995356
• Other study ID #: 2.101.2015.0076
• Status: Completed
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Other:
• Collecting cervical liquid and sera samples

Locations

Country	Name	City	State
Turkey	Ege University, Medicine Faculty, Department of Obstetrics and Gynecology	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Axonemal Dynein Heavy Chain 5		1 year
Primary	Concentration of creatine kinase		1 year