## Protocol Section
### Identification Module
**NCT ID:** NCT03767179

**Brief Title:** Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases

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

#### Organization Study ID Info
**ID:** KTU
#### Organization
**Class:** OTHER
**Full Name:** Karadeniz Technical University
### Status Module
#### Completion Date
**Date:** 2018-05-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-26

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-04-15

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2018-12-06
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-17
**Study First Submit QC Date:** 2018-12-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karadeniz Technical University

#### Responsible Party

**Investigator Affiliation:** Karadeniz Technical University

**Investigator Full Name:** Suleyman Guven

**Investigator Title:** Clinical Professor.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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

**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.

### Conditions Module

**Conditions:**

- Abortion, Missed

**Keywords:**

- Missed abortion

- Procalcitonin

- Erythrocyte sedimentation rate (ESR)

- C-reactive protein (CRP)

- Leukocyte (WBC)

### Design Module

#### Bio Spec

**Description:** Blood Serum, abortion materials

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: study

**Label:** Study Group

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: study

**Label:** Control Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

- Study Group

**Description:** procalcitonin, sedimentation, CRP, leukocyte identification

**Name:** study

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Serum leukocyte count in number

**Measure:** Serum LC

**Time Frame:** 01.01.2018- 15.02.2019

**Description:** Serum CRP level in microgram

**Measure:** CRP

**Time Frame:** 01.01.2018- 15.02.2019

**Description:** Erythrocyte sedimentation rate

**Measure:** ESR

**Time Frame:** 01.01.2018- 15.02.2019

**Description:** Serum procalcitonin level in microgram

**Measure:** Prokalsitonin

**Time Frame:** 01.01.2018- 15.02.2019

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** 60 pregnant women

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Trabzon

**Country:** Turkey

**Facility:** Karadeniz Technical University, Medical Faculty of Medicine.

**State:** Ortahisar

**Zip:** 61000

#### Overall Officials

**Official 1:**

**Affiliation:** KaradenizTU Medicine Faculty

**Name:** Suleyman Guven, Prof

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000022

- Term: Abortion, Spontaneous

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M29

- Name: Abortion, Missed

- Relevance: HIGH

- As Found: Abortion, Missed

- ID: M21

- Name: Abortion, Spontaneous

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000030

- Term: Abortion, Missed

### Misc Info Module

- Version Holder: 2024-05-24
