Unexplained Early Miscarriage : Role and Prevalence of Lower Genital Tract Infections

NCT ID: NCT03413774

Last Updated: 2018-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-01

Study Completion Date

2018-01-15

Brief Summary

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The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint

Detailed Description

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The study group included 910 women who attended Fayoum university hospital gynecology outpatient clinic for postabortive evaluation. The control group included 940 women attended outpatient clinic for any other procedure or complaint all patients were screened by serum samples to detect IgM / IgG to Chlamydia trachomatis (DRG Chlamydia Trachomatis IgM / IgG Enzyme immunoassay) and by high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR- (from +ve samples to chlamydial IgM / IgG).

Conditions

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First Trimester Abortion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Abortion group

910 women attended Fayoum University hospital outpatient gynecology clinic with recent first trimesteric spontaneous miscarriage

vaginal swab

Intervention Type PROCEDURE

high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR

Control group

940 women attended Fayoum University hospitalpresented for any other gynecological complaint

vaginal swab

Intervention Type PROCEDURE

high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR

Interventions

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vaginal swab

high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR

Intervention Type PROCEDURE

Other Intervention Names

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high vaginal swab

Eligibility Criteria

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Inclusion Criteria

* The Study group included Women with recent unexplained early miscarriage (pregnancy duration 12 weeks or less and miscarriage within 4 weeks)
* The control group included Women with any other gynecological complaint or in need of family planning

Exclusion Criteria

* Miscarriage of Pregnancy duration more than 12 ws Documented causes of miscarriage as fetal or uterine anomalies, antiphospholipid syndrome, endocrine factors….etc
* Recent antibiotic, antifungal or antiprotozoal treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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24

Identifier Type: -

Identifier Source: org_study_id

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