Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases

Research of Serum Procalcitonin, Erythrocyte Sedimentation Rate, C-Reactive Protein And Leukocyte Levels in Fertile Missed Abortion Cases

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

Study Overview

• Status: Completed
• Conditions: Abortion, Missed
• Intervention / Treatment: Diagnostic test: study

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Ortahisar
    • Trabzon, Ortahisar, Turkey, 61000
      • Karadeniz Technical University, Medical Faculty of Medicine.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

60 pregnant women

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; The study group consisted of 30 fertile, under 35 years old women who were included in the study for the first time missed abortus diagnosis.	Diagnostic test: study; procalcitonin, sedimentation, CRP, leukocyte identification
Control Group; 30 cases with the same trimester, fertile, and under 35 years old who were referred to Obstetrics clinic, who had no systemic disease, were included in the study.	Diagnostic test: study; procalcitonin, sedimentation, CRP, leukocyte identification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum LC	Serum leukocyte count in number	01.01.2018- 15.02.2019
CRP	Serum CRP level in microgram	01.01.2018- 15.02.2019
ESR	Erythrocyte sedimentation rate	01.01.2018- 15.02.2019
Prokalsitonin	Serum procalcitonin level in microgram	01.01.2018- 15.02.2019

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Suleyman Guven, Prof, KaradenizTU Medicine Faculty

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: June 17, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Procalcitonin; Missed abortion; Erythrocyte sedimentation rate (ESR); C-reactive protein (CRP); Leukocyte (WBC)
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Abortion, Missed
• Other Study ID Numbers: KTU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No