NCT03767179

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 17, 2018

Last Update Submit

June 25, 2020

Conditions

Keywords

Missed abortionProcalcitoninErythrocyte sedimentation rate (ESR)C-reactive protein (CRP)Leukocyte (WBC)

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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

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

Interventions

studyDIAGNOSTIC_TEST

procalcitonin, sedimentation, CRP, leukocyte identification

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

60 pregnant women

You may qualify if:

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

You may not qualify if:

  • Failure to meet the missed abortus diagnostic criteria (for the group of fertile missed abortus)
  • Smoking
  • Rejection to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University, Medical Faculty of Medicine.

Trabzon, Ortahisar, 61000, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum, abortion materials

MeSH Terms

Conditions

Abortion, Missed

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Suleyman Guven, Prof

    KaradenizTU Medicine Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor.

Study Record Dates

First Submitted

June 17, 2018

First Posted

December 6, 2018

Study Start

January 1, 2018

Primary Completion

April 15, 2018

Study Completion

May 15, 2018

Last Updated

June 26, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations