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

• Sponsor: Ege University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02995356
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Actual Duration (Months): 26
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Other: Collecting cervical liquid and sera samples

Study Design

• Study Type: Observational
• Actual Enrollment: 85 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Concentration of Axonemal Dynein Heavy Chain 5 [1 year]

2. Concentration of creatine kinase [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University, Medicine Faculty, Department of Obstetrics and Gynecology	Izmir		Turkey	35100

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cagdas Sahin, MD, Ege University
• ClinicalTrials.gov Identifier: NCT02995356
• Other Study ID Numbers: 2.101.2015.0076
• First Posted: Dec 16, 2016
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Cagdas Sahin, MD, Ege University: Ectopic pregnancy; Axonemal Dynein Heavy Chain 5; Creatine Kinase; Cervical fluid
• Additional relevant MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature

Study Results

No Results Posted as of Mar 28, 2019