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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767179
Other study ID # KTU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date May 15, 2018

Study information

Verified date June 2020
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim: The serum procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte values will be compared between fertile missed abortion diagnosed pregnants and fertile normal pregnants to determine the presence of subclinical infection in the etiology of missed abortion


Description:

The study group will consist of 30 fertile, under 35 years old women having for the first time missed abortus diagnosis in the Obstetrics Department of Obstetrics and Gynecology of Medicine Faculty of Karadeniz Technical University, Medical Faculty of Medicine. As control group, 30 cases with the same trimester, fertile, and under 35 years old who had referred to Obstetrics clinic, who had no systemic disease, will be included in the study. Blood samples will be collected at the time of diagnosis of the patients with missed abortion and in normal pregnancy in the week of 20th gestational week and will send to Biochemistry laboratory to examine procalcitonin, erythrocyte sedimentation rate, c-reactive protein and leukocyte values in their sera. The age, weight, gestational week, gravida (number), parity (number), abortus (number), body mass index, systemic diseases, blood group, smoking information, binary test results, and results of genetic analysis will be collected in both groups. The pathology results of the missed abortion group will also be collected. The results will statistically be compared in the SPSS 13.0 program in both groups.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 15, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- fertile, less than 20 weeks of geese who have missed abortus for the first time without systemic disease

Exclusion Criteria:

- Failure to meet the missed abortus diagnostic criteria (for the group of fertile missed abortus)

- Smoking

- Rejection to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
study
procalcitonin, sedimentation, CRP, leukocyte identification

Locations

Country Name City State
Turkey Karadeniz Technical University, Medical Faculty of Medicine. Trabzon Ortahisar

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum LC Serum leukocyte count in number 01.01.2018- 15.02.2019
Primary CRP Serum CRP level in microgram 01.01.2018- 15.02.2019
Primary ESR Erythrocyte sedimentation rate 01.01.2018- 15.02.2019
Primary Prokalsitonin Serum procalcitonin level in microgram 01.01.2018- 15.02.2019
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